Category

Diagnostic Devices Recalls

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

1,863 recalls
RecallFDA
Euro Diagnostica Ab
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked i...
Diagnostic Devices·501 affected·May 22, 2017
High RiskFDA
Beckman Coulter Inc.
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting syst...
Diagnostic Devices·43 affected·May 22, 2017
High RiskFDA
Sentinel Ch Spa
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in...
Diagnostic Devices·2,356 affected·May 22, 2017
High RiskFDA
Fisher Diagnostics
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- F...
Diagnostic Devices·331 affected·May 19, 2017
High RiskFDA
Biomerieux Inc
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Diagnostic Devices·1,520,000 affected·May 16, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips DigitalDiagnost 3.1.x X-Ray System
Diagnostic Devices·132 affected·May 11, 2017
High RiskFDA
Cell Marque Corporation
HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagn...
Diagnostic Devices·11 affected·May 5, 2017
High RiskFDA
Cell Marque Corporation
H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specif...
Diagnostic Devices·5 affected·May 5, 2017
High RiskFDA
Cell Marque Corporation
Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Speci...
Diagnostic Devices·1 affected·May 5, 2017
High RiskFDA
Cell Marque Corporation
Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Spe...
Diagnostic Devices·3 affected·May 5, 2017
High RiskFDA
Cell Marque Corporation
Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte S...
Diagnostic Devices·10 affected·May 5, 2017
High RiskFDA
Cell Marque Corporation
Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vit...
Diagnostic Devices·2 affected·May 5, 2017
High RiskFDA
Toshiba American Medical Systems Inc
XARIO 200 TUS-X200 diagnostic ultrasound system
Diagnostic Devices·1 affected·May 1, 2017
High RiskFDA
Toshiba American Medical Systems Inc
APLIO 500 TUS-A500 diagnostic ultrasound system
Diagnostic Devices·307 affected·May 1, 2017
High RiskFDA
Exact Sciences Corporation
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a...
Diagnostic Devices·15 affected·Apr 28, 2017
RecallFDA
Randox Laboratories
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on ...
Diagnostic Devices·198 affected·Apr 27, 2017
High RiskFDA
Beckman Coulter Inc.
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(...
Diagnostic Devices·3,158 affected·Apr 24, 2017
High RiskFDA
Jas Diagnostics Inc.
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Diagnostic Devices·14,064 affected·Apr 21, 2017
High RiskFDA
Abbott Laboratories
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determinat...
Diagnostic Devices·7,981 affected·Apr 18, 2017
High RiskFDA
Biomerieux Sa
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of b...
Diagnostic Devices·1,585 affected·Apr 13, 2017
High RiskFDA
Diagnostic Hybrids, Inc.
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The...
Diagnostic Devices·101 affected·Apr 4, 2017
High RiskFDA
Beckman Coulter Inc.
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) conc...
Diagnostic Devices·12,665 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human ser...
Diagnostic Devices·50,645 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high dens...
Diagnostic Devices·91,996 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human se...
Diagnostic Devices·128,718 affected·Apr 3, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for...
Diagnostic Devices·188 affected·Apr 3, 2017
High RiskFDA
Remel Inc
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid m...
Diagnostic Devices·1,159 affected·Mar 24, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Diagnostic Devices·19 affected·Mar 21, 2017
High RiskFDA
Roche Diagnostics Corporation
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cob...
Diagnostic Devices·3,946 affected·Mar 21, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usa...
Diagnostic Devices·13,064,500 affected·Mar 16, 2017
High RiskFDA
Richard-allan Scientific Company
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chr...
Diagnostic Devices·390 affected·Mar 15, 2017
High RiskFDA
Hans Pausch Rontgengeratebau Gmbh
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagn...
Diagnostic Devices·10 affected·Mar 14, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay ...
Diagnostic Devices·1,900 affected·Mar 8, 2017
High RiskFDA
Beckman Coulter Inc.
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Syst...
Diagnostic Devices·851 affected·Mar 7, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35...
Diagnostic Devices·6,324 affected·Mar 7, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassa...
Diagnostic Devices·851 affected·Mar 7, 2017
High RiskFDA
Beckman Coulter Inc.
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diag...
Diagnostic Devices·851 affected·Mar 7, 2017
High RiskFDA
Liebel-flarsheim Company Llc
Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic proc...
Diagnostic Devices·28 affected·Feb 27, 2017
High RiskFDA
Helena Laboratories, Inc.
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPOR...
Diagnostic Devices·27 affected·Feb 24, 2017
RecallFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT...
Diagnostic Devices·314 affected·Feb 23, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comp...
Diagnostic Devices·11 affected·Feb 23, 2017
CriticalFDA
Merit Medical Systems, Inc.
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelu...
Diagnostic Devices·1,265 affected·Feb 16, 2017
High RiskFDA
Euro Diagnostica Ab
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides pre...
Diagnostic Devices·534 affected·Feb 14, 2017
High RiskFDA
Abbott Laboratories
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyze...
Diagnostic Devices·116 affected·Feb 13, 2017
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinic...
Diagnostic Devices·2 affected·Feb 13, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuo...
Diagnostic Devices·17 affected·Feb 2, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and RE...
Diagnostic Devices·94 affected·Feb 1, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The ...
Diagnostic Devices·1,488,800 affected·Jan 16, 2017