Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Ortho-clinical Diagnostics
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Ver...
Diagnostic Devices·60 affected·Sep 7, 2016
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four flor...
Diagnostic Devices·148 affected·Sep 6, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (...
Diagnostic Devices·5 affected·Aug 30, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista IRON Flex reagent cartridges
Diagnostic Devices·30,247 affected·Aug 25, 2016
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Dimension IRON Flex reagent cartridges
Diagnostic Devices·38,230 affected·Aug 25, 2016
High RiskFDA
R & D Systems, Inc.
R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentratio...
Diagnostic Devices·725 affected·Aug 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 103...
Diagnostic Devices·177 affected·Aug 24, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), U...
Diagnostic Devices·359 affected·Aug 24, 2016
High RiskFDA
Microgenics Corporation
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The...
Diagnostic Devices·163 affected·Aug 15, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Diagnostic Devices·0 affected·Aug 9, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myo...
Diagnostic Devices·2,248 affected·Aug 8, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Diagnostic Devices·93 affected·Aug 4, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Diagnostic Devices·5,991 affected·Aug 3, 2016
CriticalFDA
Bayer Healthcare
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The M...
Diagnostic Devices·165 affected·Aug 2, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227,...
Diagnostic Devices·2,883 affected·Jul 28, 2016
High RiskFDA
Tecan Us, Inc.
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density)...
Diagnostic Devices·19 affected·Jul 25, 2016
High RiskFDA
Tecan Us, Inc.
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high perf...
Diagnostic Devices·11 affected·Jul 25, 2016
High RiskFDA
Tecan Us, Inc.
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of l...
Diagnostic Devices·5 affected·Jul 25, 2016
RecallFDA
Sterling Diagnostics, Inc.
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are ...
Diagnostic Devices·182 affected·Jul 20, 2016
RecallFDA
Sterling Diagnostics, Inc.
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMAB...
Diagnostic Devices·165 affected·Jul 20, 2016
RecallFDA
Sterling Diagnostics, Inc.
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES ...
Diagnostic Devices·97 affected·Jul 20, 2016
RecallFDA
Sterling Diagnostics, Inc.
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analyt...
Diagnostic Devices·173 affected·Jul 20, 2016
High RiskFDA
Philips Electronics North America Corporation
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
Diagnostic Devices·993 affected·Jul 19, 2016
High RiskFDA
Cepheid
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRS...
Diagnostic Devices·68 affected·Jul 18, 2016
RecallFDA
Becton, Dickinson And Company, Bd Biosciences
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and...
Diagnostic Devices·14,089 affected·Jul 18, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clin...
Diagnostic Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems...
Diagnostic Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (I...
Diagnostic Devices·29 affected·Jul 14, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855...
Diagnostic Devices·1,620 affected·Jul 14, 2016
High RiskFDA
Diasorin Inc.
LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) inten...
Diagnostic Devices·10,739 affected·Jul 13, 2016
RecallFDA
Elitech Group B.v.
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated cli...
Diagnostic Devices·89 affected·Jul 12, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified v...
Diagnostic Devices·0 affected·Jul 11, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Al...
Diagnostic Devices·0 affected·Jul 11, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a ...
Diagnostic Devices·0 affected·Jul 11, 2016
CriticalFDA
Alere San Diego, Inc.
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5...
Diagnostic Devices·0 affected·Jul 11, 2016
RecallFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Diagnostic Devices·6 affected·Jul 11, 2016
RecallFDA
Branan Medical Corporation
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for t...
Diagnostic Devices·96 affected·Jul 5, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the perf...
Diagnostic Devices·1,621 affected·Jun 22, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylli...
Diagnostic Devices·658 affected·Jun 17, 2016
High RiskFDA
Ab Sciex
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mas...
Diagnostic Devices·124 affected·Jun 16, 2016
High RiskFDA
Ab Sciex
AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD se...
Diagnostic Devices·28 affected·Jun 16, 2016
High RiskFDA
Ab Sciex
AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD se...
Diagnostic Devices·2 affected·Jun 16, 2016
High RiskFDA
Bayer Healthcare
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRA...
Diagnostic Devices·42 affected·Jun 9, 2016
High RiskFDA
Beckman Coulter Inc.
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantit...
Diagnostic Devices·205,744 affected·Jun 8, 2016
High RiskFDA
Bbi Solutions Oem Ltd
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin ...
Diagnostic Devices·420 affected·Jun 1, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ...
Diagnostic Devices·53,897 affected·May 26, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent ...
Diagnostic Devices·1,517 affected·May 24, 2016
High RiskFDA
Csl Behring Gmbh
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantita...
Diagnostic Devices·898 affected·May 17, 2016