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    GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660 PRO, CT OPTIMA 660 PRO LONG BJG P2., CT OPTIMA 660 PRO MID, CT OPTIMA 660 PRO MID HN P20, CT OPTIMA 660S LNG HN P20, CT OPTIMA CT660 GT 1700, CT OPTIMA CT660 GT1700, CT OPTIMA CT660 GT1700V, CT OPTIMA CT660 PRO GT1700, CT OPTIMA CT660 PRO LNG P1.5 H, CT OPTIMA CT660 PRO MID P1.5 H, CT OPTIMA CT660 SE GT 1700, CT OPTIMA CT660 SE GT2000, CT660, CT660 ASIR OPT, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT2000 MKE25, OPTI660_A_G_1.5, OPTI660_A_L_2.0, OPTI660_N_G_1.5, OPTI660_N_G_2.0, OPTI660_N_L_2.0, OPTIMA 660 DIVA, OPTIMA 660 LNG HN P20, OPTIMA 660 LNG HN P20, OPTIMA 660 LONG, OPTIMA 660 LONG BJG P2.0, OPTIMA 660 LONG WSO, OPTIMA 660 MID, OPTIMA 660 MID BJG P1.5, OPTIMA 660 MID HN P20, OPTIMA 660 MID HN P20, OPTIMA 660 MID WSO, OPTIMA 660 PRO LGN HN P20, OPTIMA 660 PRO LONG BJG P1.5_, OPTIMA 660 PRO LONG BJG P2, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG WSO, OPTIMA 660 PRO MID BJG P1.5, OPTIMA 660 PRO MID BJG P2.0, OPTIMA 660 PRO MID H, OPTIMA 660 PRO MID HN P20, OPTIMA 660 PRO MID WSO, OPTIMA 660 WSO, OPTIMA 660S 32 OPTIMA 660S 32 SLICE LONG WSO, OPTIMA 660S 32 SLICE MID WSO, OPTIMA 660S LNG HN P20, OPTIMA 660S MID BJG P2.0, OPTIMA 660S PRO 32 SLICE M WSO, OPTIMA 660S PRO LONG BJG P2.0, OPTIMA 660S PRO MID BJG P1.5, OPTIMA 660S WSO, OPTIMA CT 660 FREEDOM, OPTIMA CT660, OPTIMA CT660 2ND EDITION, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR ADV 2ND, OPTIMA CT660 FREEDOM, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG HN2, OPTIMA CT660 FREEDOM LG HN2.5, OPTIMA CT660 FREEDOM MD, OPTIMA CT660 FREEDOM MD BJG2., OPTIMA CT660 GS, OPTIMA CT660 GT 1700 BJG2, OPTIMA CT660 GT 1700 BJG2.5, OPTIMA CT660 GT 1700 HN P2, OPTIMA CT660 GT 1700 HN P2., OPTIMA CT660 GT 1700 HN P2.5, OPTIMA CT660 GT 2000 HN P2.5, OPTIMA CT660 GT1700, OPTIMA CT660 GT1700 MKE2.5, OPTIMA CT660 GT1700 PHASE 1.5, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000 PHASE 1.5, OPTIMA CT660 LITE, OPTIMA CT660 LITE HN P2.5, OPTIMA CT660 MID P1.5 HINO, OPTIMA CT660 MID P20, OPTIMA CT660 MID P2000, OPTIMA CT660 PRO, OPTIMA CT660 PRO GT 2000, OPTIMA CT660 PRO GT1700, OPTIMA CT660 PRO GT1700 ASIR, OPTIMA CT660 PRO GT1700 P20, OPTIMA CT660 PRO GT1700 PHASE, OPTIMA CT660 PRO GT1700 PHASE 1.5, OPTIMA CT660 PRO GT1700V, OPTIMA CT660 PRO GT1700V ASIR, OPTIMA CT660 PRO GT2000, OPTIMA CT660 PRO GT2000 PHASE, OPTIMA CT660 PRO GT2000 PHASE 1.5, OPTIMA CT660 PRO LNG, OPTIMA CT660 PRO LNG P1.5, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LONG BJG P2.0, OPTIMA CT660 PRO LONG P2.0, OPTIMA CT660 PRO MID P1.5, OPTIMA CT660 PRO MID P1.5 H, OPTIMA CT660 PRO MID P1.5 HINO, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700 BJG, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 HN2, OPTIMA CT660 SE GT 2000, OPTIMA CT660 SE GT 2000 BJG, OPTIMA CT660 SE GT 2000 BJG2., OPTIMA CT660 SE GT 2000 BJG2.5, OPTIMA CT660 SE GT 2000 HN2, OPTIMA CT660 SE GT 2000 HN2.5, OPTIMA CT660 SE GT2000 MKE2.5, OPTIMA CT660 SE WITH ASIR, OPTIMA CT660 W/PRO PKG-BR, OPTIMA CT660 W/PRO PKG-LA, OPTIMA CT660-64 USA, OPTIMA CT660S, OPTIMA CT660S, OPTIMA CT660S 32 SLICE GT1700, OPTIMA CT660S 32 SLICE HINO, OPTIMA CT660S GT, OPTIMA CT660S GT 1700 HN2.5, OPTIMA CT660S GT 2000, OPTIMA CT660S GT 2000 BJG2.5, OPTIMA CT660S GT 2000 HN2.5, OPTIMA CT660S GT1700 BJG P2.5, OPTIMA CT660S GT1700 HN P2.5, OPTIMA CT660S PRO 32 HINO, OPTIMA CT660S PRO 32 SLICE, OPTIMA CT660S PRO 32 SLICE GT2, OPTIMA CT660S PRO P1.5 HINO, OPTIMACT660_A_G, OPTIMACT660_A_L, OPTIMACT660_N_G, OPTIMACT660_N_L, REVOLUTION EVO, REVOLUTION EVO WITH GT2000 TABLE (H

    FDA Recall
    Terminated ·GE Healthcare Japan Corporation Ge Herusukea.Japan Kabu 4 Chome 7-127 Asahigaoka Hino Japan·Product code JAK·April 27, 2018

    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code KTT·February 22, 2006

    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LIP·March 16, 2005

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Recall
    Terminated ·Organon Teknika Inc·Product code LON·January 11, 2019

    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DJG·February 18, 2014

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code JJW·February 6, 2014

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DLJ·February 6, 2014

    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·August 23, 2011

    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code LAS·October 3, 2013

    Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIF·August 5, 2011

    Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIS·September 8, 2011

    Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·October 11, 2011

    Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire..

    FDA Recall
    Terminated ·The Contact Lens Store, Inc.·Product code LPL·June 7, 2004

    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CGN·November 6, 2013

    STA SYSTEM CONROL N + P (ref. 00678)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·November 18, 2019

    Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

    ADVIA Centaur Folate (FOL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018

    HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GGN·November 15, 2013

    PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

    FDA Recall
    Terminated ·TEI Biosciences·Product code KGN·June 15, 2017