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    R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code JNM·August 24, 2016

    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code MRG·September 11, 2018

    ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials distributed by Horiba Ltd., Kyoto, Japan

    FDA Recall
    Terminated ·R & D Systems, Inc·Product code JPK·April 15, 2004

    Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code JNM·November 1, 2018

    R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H; (6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H; (7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H; (8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H; (9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H. Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes. OEM/Own-label distributor labels: (1) Alere 380 Hemo Control (L-N-H), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; control lot #B1122N, no UDI (2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N (3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N (4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N. (5) Elite 3 HEM Control Normal, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N; (6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10 (7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3; kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N. (8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D; and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D. (9) mindray BC-3D, P/N 040-001423-00. (10) MINDRAY BC-3D CONTROL, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; kit lot #B1122, control lot #B1122N. (11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N. (12) Nihon Kohden MEK-3D Hematology Control, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN. (13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN. (14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H. (15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N. (17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N;

    FDA Recall
    Open, Classified ·R & D Systems, Inc.·Product code JPK·November 7, 2022

    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

    FDA Recall
    Terminated ·R & D Systems, Inc.·Product code JNM·January 20, 2021

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    FDA Recall
    Open, Classified ·R & D Systems, Inc.·Product code GGT·June 14, 2022

    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (002-E-32034) n) D 3.2MM X 36MM (002-E-32036) o) D 3.2MM X 38MM (002-E-32038) p) D 3.2MM X 40MM (002-E-32040) q) D 3.2MM X 42MM (002-E-32042) r) D 3.2MM X 44MM (002-E-32044) s) D 3.2MM X 46MM (002-E-32046) t) D 3.2MM X 48MM (002-E-32048) u) D 3.2MM X 50MM (002-E-32050)

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

    FDA Recall
    Terminated ·Solta Medical, Inc.·Product code ONG·December 15, 2010

    Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc., Hercules, CA 4000 Alfred Nobel Dr Hercules CA 94547-1803·Product code LCP·September 8, 2010

    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 0 SUTURE, REF 5100-0016, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code MBI·September 20, 2011

    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 0 SUTURE, REF 5100-0012, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code MBI·September 20, 2011

    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 0 SUTURE, REF 5100-008, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code MBI·September 20, 2011

    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004,1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code MBI·September 20, 2011

    BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013

    FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code NTE·March 3, 2014

    OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product or as private labeled material labeled as follows: (1) SURE CHECK™ ONE STEP Pregnancy Test --- 1 TEST; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00110 3; Catalog # PT110SURE/12 (ordered by Dean Distribution, Fred's DC Memphis, Health Enterprises, Healthcare Products, Mason Distribution, Par-Med). (2) SURE CHECK™ ONE STEP Pregnancy Test --- 2 TESTS; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00112 7; Catalog # PT112/24 (Fred's DC Memphis). (3) exact™ pregnancy test --- Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 66207 3; Catalog # PT110-N4 (Neuco). (4) exact™ pregnancy test --- 2 tests; Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 68179; Catalog # PT112-N4 (Neuco). (5) OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY TEST (TEST DE GROSSESSE EN UNE ETAPE) --- 1 TEST --- PRODUCT OF U.S.A./PRODUIT DES E.-U. IMPORTED FOR/IMPORTE POUR: SOBEYS MISSISSAUGA, ON L4V 1W2. Manufactured by/Fabriqu par: CHEMBIO DIAGNOSTIC SYSTEMS, INC.; UPC 0 61925 57608; Catalog # PT110-N7 (Neuco). (6) BODY BASICS™ Pregnancy Test (Test de grossesse) --- 1 Test --- PRODUCT OF U.S.A./PRODUIT DES E.-U.A. MANUFACTURED BY/FABRIQUE PAR: CHEMBIO DIAGNOSTIC SYSTEMS, INC. IMPORTED FOR/IMPORTE POUR: THE GREAT ATLANTIC & PACIFIC COMPANY OF CANADA LTD. TORONTO, CANADA M5W1A6; UPC 0 57627 71110 9; Catalog # PT110-N6/12 (Neuco) (7) Option+ TEST DE GROSSESSE UNE ETAPE/ONE STEP PREGNANCY TEST --- Produit des E.U/Product of U.S.A. Fabrique pour/Manufactured for: UNIPRIX Inc. Montreal H1S 3G7; UPC 7 71290 05402 7; Catalog # PT110-N2 (Neuco). (8) True-Test™ Pregnancy Test Kit (Examen del Embarazo) One Step Testing --- 1 Test --- Distributed By: Ultras Pharmaceuticals, Inc. P.O. Box 370669 Las Vegas, NV 89137 U.S.A.; UPC 0 61406 37505 5; Catalog # PT110-R1 (Ultras). (9) Shaw's ONE-STEP Pregnancy Test ---1 TEST --- DISTRIBUTED BY SHAW'S SUPERMARKETS, INC. E. BRIDGEWATER, MA 02333, Made in USA; UPC 0 45674 65589 7; Catalog # PT110-S1 (Millbrook Distribution). (10) Harris Teeter Pregnancy Test Kits One Step Easy to use Pregnancy Test Kit --- Two Home Test Kits --- PROUDLY DISTRIBUTED BY: HARRIS TEETER MATTHEWS, NC 28105; UPC 0 72036 72061 0; Catalog # PT112-R2 (Harris Teeter). Bulk packaged product is assigned Catalog # PT110, with varying quantities (ordered by Savyon Diagnostics & Pruebas Moderna del Istmo). --- 510(k) K961965.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004

    Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005

    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL, for cemented use only, sterile, Zimmer, Warsaw, IN; Model Number: 6420-00-200. The Natural-Knee II System Cemented Modular Tibial Baseplate is a nonporous component which may be used in total knee replacement surgery. The baseplate is intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·March 18, 2009