Category

Diagnostic Devices Recalls

1,863 diagnostic devices recalls on record from CPSC, FDA, and USDA.

1,863 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista Syste...
Diagnostic Devices·59,735 affected·May 8, 2012
High RiskFDA
Becton Dickinson & Co.
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decoloriz...
Diagnostic Devices·539 affected·Apr 12, 2012
High RiskFDA
Beckman Coulter Inc.
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematolo...
Diagnostic Devices·1,281 affected·Apr 3, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Diagnostic Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Medtest Holdings, Inc.
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is ...
Diagnostic Devices·270 affected·Mar 13, 2012
RecallFDA
Roche Molecular Systems, Inc.
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800...
Diagnostic Devices·264 affected·Feb 24, 2012
RecallFDA
Medtest Holdings, Inc.
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Us...
Diagnostic Devices·119 affected·Feb 15, 2012
High RiskFDA
Accumetrics Inc
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay u...
Diagnostic Devices·26,075 affected·Feb 6, 2012
High RiskFDA
Accumetrics Inc
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or poi...
Diagnostic Devices·1,167 affected·Feb 6, 2012
High RiskFDA
Abbott Point Of Care Inc.
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measuremen...
Diagnostic Devices·368,149 affected·Feb 1, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human ...
Diagnostic Devices·199 affected·Dec 20, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human...
Diagnostic Devices·199 affected·Dec 20, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human a...
Diagnostic Devices·199 affected·Dec 20, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and stai...
Diagnostic Devices·41 affected·Dec 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and ...
Diagnostic Devices·41 affected·Dec 13, 2011
High RiskFDA
Hyphen Biomed
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and ...
Diagnostic Devices·94 affected·Nov 9, 2011
High RiskFDA
Hyphen Biomed
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG,...
Diagnostic Devices·30 affected·Nov 9, 2011
High RiskFDA
Shimadzu Medical Systems
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06...
Diagnostic Devices·308 affected·Oct 28, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System ...
Diagnostic Devices·2,442 affected·Oct 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456;...
Diagnostic Devices·2,442 affected·Oct 13, 2011
Medium RiskFDA
Beckman Coulter Inc.
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) level...
Diagnostic Devices·117,385 affected·Oct 11, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Em...
Diagnostic Devices·11 affected·Oct 6, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro d...
Diagnostic Devices·1,756 affected·Aug 1, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro d...
Diagnostic Devices·432 affected·Aug 1, 2011
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the A...
Diagnostic Devices·6,634 affected·Jul 27, 2011
RecallFDA
Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology in...
Diagnostic Devices·623 affected·Mar 24, 2011
RecallFDA
Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology in...
Diagnostic Devices·901 affected·Mar 24, 2011
RecallFDA
Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology in...
Diagnostic Devices·197 affected·Mar 24, 2011
High RiskFDA
Canon Inc.
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices ar...
Diagnostic Devices·468 affected·Nov 1, 2010
High RiskFDA
Beckman Coulter Inc.
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. P...
Diagnostic Devices·718 affected·Sep 22, 2010
RecallFDA
Clinical Diagnostic Solutions
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology...
Diagnostic Devices·532 affected·Aug 4, 2010
RecallFDA
Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hema...
Diagnostic Devices·690 affected·Aug 4, 2010
RecallFDA
Medtest Holdings, Inc.
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to us...
Diagnostic Devices·323 affected·Jul 21, 2009
High RiskFDA
Alere San Diego, Inc.
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be ...
Diagnostic Devices·45,638 affected·May 28, 2009
High RiskFDA
Regulatory Insight, Inc
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiolo...
Diagnostic Devices·43 affected·Jul 1, 2008
High RiskFDA
Ventana Medical Systems Inc
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usag...
Diagnostic Devices·1,217 affected·Jun 12, 2008
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and ...
Diagnostic Devices·264 affected·May 1, 2008
High RiskFDA
General Electric Med Systems Llc
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revo...
Diagnostic Devices·3,796 affected·May 31, 2006
High RiskFDA
General Electric Med Systems Llc
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use ...
Diagnostic Devices·3,796 affected·May 31, 2006