24 results
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12ms
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Sources: EU EUDAMED, US FDA
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
FDA Recall
Terminated
·Kim's Trading Inc·Product code LPM·May 17, 2010
Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
FDA Recall
Terminated
·Centurion Medical Products Corporation·Product code HHM·December 11, 2019
Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature, Michclone Associates, Madison Heights, MI 48071. For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.
FDA Recall
Terminated
·MichClone Associates, Inc.·Product code GHM·February 23, 2012
Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml.
FDA Recall
Terminated
·Chembio Diagnostic System Inc·Product code GHM·December 16, 2005
BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA . For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.
FDA Recall
Terminated
·MichClone Associates, Inc.·Product code GHM·February 23, 2012
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
FDA Recall
Terminated
·Hologic, Inc·Product code HHM·October 28, 2016
Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.
FDA Recall
Terminated
·MichClone Associates, Inc.·Product code GHM·February 23, 2012
Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
FDA Recall
Terminated
·Fisher Diagnostic, A Company of Fisher Scientific LLC·Product code GHM·September 3, 2004
Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·July 20, 2007
In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).
FDA Recall
Terminated
·Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila·Product code MGU·March 23, 2005
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JJE·September 8, 2006
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code JIS·March 6, 2008
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIS·September 7, 2006
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
FDA Recall
Terminated
·Aspen Surgical Puerto Rico Corp. Rd 183 Km 20.3 Las·Product code GES·June 27, 2016
Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIT·September 7, 2006
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIT·September 7, 2006
Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCD·October 26, 2007
ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.
FDA Recall
Terminated
·Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LOL·December 30, 2009