102 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPR·September 16, 2016
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 1, 2018
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA Enforcement
Class II
·Terminated·C-RAD POSITIONING AB·July 21, 2021
Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017
Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code JDB·October 24, 2017
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA Recall
Terminated
·C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden·Product code IYE·August 6, 2020
X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code rad·September 7, 2004
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories·September 26, 2012
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories·October 30, 2013
BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LKJ·November 13, 2007
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
FDA Recall
Terminated
·Bio-Rad Laboratories·January 7, 2008
BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LSE·November 13, 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
BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LSE·November 13, 2007
Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog numbers: 30445 - 8 wells, 48 tests and 30447 - 8 well, 192 tests.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code DBL·July 29, 2008
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
BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LIP·November 13, 2007
Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code DBM·July 29, 2008