Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Philips Medical Systems, Inc.
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height A...
Diagnostic Devices·420 affected·May 15, 2014
High RiskFDA
Beckman Coulter Inc.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes...
Diagnostic Devices·82 affected·May 14, 2014
RecallFDA
Agfa Healthcare Corp.
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the ...
Diagnostic Devices·1 affected·May 13, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chem...
Diagnostic Devices·612 affected·May 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medic...
Diagnostic Devices·433 affected·May 9, 2014
High RiskFDA
Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnost...
Diagnostic Devices·317 affected·May 5, 2014
High RiskFDA
Alere San Diego, Inc.
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Aler...
Diagnostic Devices·373 affected·May 2, 2014
High RiskFDA
Abbott Laboratories
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglo...
Diagnostic Devices·183 affected·Apr 30, 2014
High RiskFDA
Agfa Corp.
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creat...
Diagnostic Devices·0 affected·Apr 30, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, ...
Diagnostic Devices·5 affected·Apr 24, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ,...
Diagnostic Devices·2,458 affected·Apr 23, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discover...
Diagnostic Devices·1,548 affected·Apr 23, 2014
High RiskFDA
Meridian Bioscience Inc
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Mole...
Diagnostic Devices·35 affected·Apr 22, 2014
High RiskFDA
Leica Microsystems, Inc.
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered sal...
Diagnostic Devices·180 affected·Apr 18, 2014
RecallFDA
Gen-probe Inc
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Co...
Diagnostic Devices·4,740 affected·Apr 17, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety...
Diagnostic Devices·6 affected·Apr 17, 2014
High RiskFDA
Nanosphere, Inc.
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mu...
Diagnostic Devices·580 affected·Apr 17, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with ...
Diagnostic Devices·49 affected·Apr 16, 2014
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, us...
Diagnostic Devices·4 affected·Apr 14, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
Diagnostic Devices·597 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitativ...
Diagnostic Devices·40,266 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clin...
Diagnostic Devices·31 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative ...
Diagnostic Devices·12,787 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Diagnostic Devices·835 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the...
Diagnostic Devices·155,345 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Diagnostic Devices·82 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the ...
Diagnostic Devices·22,770 affected·Apr 10, 2014
High RiskFDA
Bio-rad Laboratories, Inc.
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vit...
Diagnostic Devices·457 affected·Apr 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, ...
Diagnostic Devices·247 affected·Apr 8, 2014
High RiskFDA
Bd Biosciences, Systems & Reagents
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified a...
Diagnostic Devices·12 affected·Apr 4, 2014
High RiskFDA
Ge Healthcare
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare...
Diagnostic Devices·297 affected·Apr 3, 2014
High RiskFDA
Neo Metrics, Inc.
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactur...
Diagnostic Devices·1,256 affected·Mar 31, 2014
High RiskFDA
Branan Medical Corporation
ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and dru...
Diagnostic Devices·9,800 affected·Mar 26, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Diagnostic Devices·1,656 affected·Mar 26, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN...
Diagnostic Devices·49,123 affected·Mar 25, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantit...
Diagnostic Devices·20 affected·Mar 20, 2014
High RiskFDA
Remel Inc
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pn...
Diagnostic Devices·72 affected·Mar 17, 2014
High RiskFDA
Philips Medical Systems, Inc.
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Diagnostic Devices·985 affected·Mar 17, 2014
High RiskFDA
Remel Inc
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxo...
Diagnostic Devices·2 affected·Mar 17, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips M...
Diagnostic Devices·157 affected·Mar 11, 2014
High RiskFDA
Biomerieux Sa
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test in...
Diagnostic Devices·33,853 affected·Mar 6, 2014
High RiskFDA
Biomerieux Sa
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs a...
Diagnostic Devices·33,853 affected·Mar 6, 2014
High RiskFDA
Biomerieux Sa
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included...
Diagnostic Devices·33,853 affected·Mar 6, 2014
High RiskFDA
Alfa Wassermann, Inc.
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and l...
Diagnostic Devices·1,047 affected·Mar 5, 2014
High RiskFDA
Alfa Wassermann, Inc.
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and l...
Diagnostic Devices·731 affected·Mar 5, 2014
High RiskFDA
Bio-rad Laboratories, Inc.
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercu...
Diagnostic Devices·483 affected·Feb 27, 2014
High RiskFDA
Leica Microsystems, Inc.
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in...
Diagnostic Devices·33 affected·Feb 26, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the V...
Diagnostic Devices·583 affected·Feb 20, 2014