270 results
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Sources: EU EUDAMED, US FDA
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Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LOM·August 27, 2004
Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LOM·December 15, 2005
AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code LOM·April 23, 2007
VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics Forest Farm Estate, Whitechurch Cardiff United Kingdom·Product code LOM·February 1, 2007
Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LOM·May 14, 2007
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·August 20, 2013
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018
AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code LOM·April 23, 2007
ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LOM·May 14, 2007
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code LOM·December 18, 2012
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LOM·October 25, 2013
ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LOM·May 14, 2007
Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·August 11, 2008
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
FDA Recall
Terminated
·Diasorin Inc.·Product code LOM·August 19, 2010
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LOM·September 15, 2014
Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code LOM·November 5, 2003
AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20;
FDA Recall
Terminated
·Abbott Laboratories·Product code LOM·January 19, 2009
AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code LOM·April 23, 2007
Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code LOM·October 1, 2007
VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code LOM·November 1, 2012