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.
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The...
Diagnostic Devices·217 affected·Sep 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component...
Diagnostic Devices·264 affected·Sep 26, 2018
High RiskFDA
Becton Dickinson & Co.
BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with ap...
Diagnostic Devices·49 affected·Sep 24, 2018
High RiskFDA
Becton Dickinson & Co.
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX Sy...
Diagnostic Devices·23 affected·Sep 24, 2018
High RiskFDA
Beckman Coulter Inc.
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage...
Diagnostic Devices·0 affected·Sep 18, 2018
High RiskFDA
Biomerieux Sa
NucliSENS¿ Magnetic Extraction Reagents
Diagnostic Devices·42 affected·Sep 17, 2018
High RiskFDA
Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for...
Diagnostic Devices·12,700 affected·Sep 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro ...
Diagnostic Devices·3,956 affected·Sep 7, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic t...
Diagnostic Devices·18,396 affected·Sep 7, 2018
High RiskFDA
Vital Scientific N.v.
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer,...
Diagnostic Devices·192 affected·Sep 7, 2018
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 te...
Diagnostic Devices·18,038 affected·Sep 5, 2018
High RiskFDA
Leica Microsystems, Inc.
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for ...
Diagnostic Devices·1 affected·Sep 4, 2018
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantit...
Diagnostic Devices·6,630 affected·Aug 28, 2018
High RiskFDA
Life Technologies, Corp.
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
Diagnostic Devices·1,329 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Diagnostic Devices·1,912 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
Diagnostic Devices·240 affected·Aug 24, 2018
High RiskFDA
Life Technologies, Corp.
Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Diagnostic Devices·41 affected·Aug 24, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to prov...
Diagnostic Devices·1,228 affected·Aug 23, 2018
High RiskFDA
The Binding Site Group, Ltd.
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage:...
Diagnostic Devices·462 affected·Aug 12, 2018
RecallFDA
Medtest Holdings, Inc.
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific ...
Diagnostic Devices·22 affected·Aug 10, 2018
CriticalFDA
Ventana Medical Systems Inc
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic...
Diagnostic Devices·195 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro di...
Diagnostic Devices·2,753 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Diagnostic Devices·3,068 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnost...
Diagnostic Devices·354 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Diagnostic Devices·559 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
Diagnostic Devices·120 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
Diagnostic Devices·2,231 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic ...
Diagnostic Devices·2,172 affected·Aug 2, 2018
CriticalFDA
Ventana Medical Systems Inc
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunoh...
Diagnostic Devices·1,655 affected·Aug 2, 2018
High RiskFDA
Instrumentation Laboratory Co.
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplast...
Diagnostic Devices·9,751 affected·Aug 1, 2018
CriticalFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The U...
Diagnostic Devices·5,414 affected·Jul 30, 2018
CriticalFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same ...
Diagnostic Devices·2,059 affected·Jul 30, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assa...
Diagnostic Devices·97 affected·Jul 24, 2018
High RiskFDA
Diagnostica Stago, Inc.
Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 0...
Diagnostic Devices·5 affected·Jul 24, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB ...
Diagnostic Devices·1,870 affected·Jul 24, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centau...
Diagnostic Devices·2 affected·Jul 24, 2018
High RiskFDA
Diagnostica Stago, Inc.
Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. ...
Diagnostic Devices·24,043 affected·Jul 24, 2018
High RiskFDA
Sedecal S.a.
Sedecal NOVA FA DR System. for diagnostic radiography.
Diagnostic Devices·145 affected·Jul 18, 2018
High RiskFDA
Abbott Laboratories, Inc
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic...
Diagnostic Devices·3,675 affected·Jul 17, 2018
High RiskFDA
Abbott Laboratories, Inc
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnosti...
Diagnostic Devices·1,666 affected·Jul 17, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Diagnostic Devices·7,880 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
Diagnostic Devices·1,955 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Diagnostic Devices·1,790 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Diagnostic Devices·68,230 affected·Jul 12, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Product...
Diagnostic Devices·128,196 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitr...
Diagnostic Devices·627,543 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products ...
Diagnostic Devices·420,105 affected·Jul 11, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·107 affected·Jun 29, 2018