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.
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Flui...
Diagnostic Devices·3,395 affected·Dec 19, 2012
High RiskFDA
Ortho-clinical Diagnostics
Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartrid...
Diagnostic Devices·15,891 affected·Dec 13, 2012
High RiskFDA
Abbott Laboratories
Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-...
Diagnostic Devices·28,600 affected·Dec 12, 2012
High RiskFDA
Becton Dickinson & Co.
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 ...
Diagnostic Devices·27 affected·Dec 11, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.
Diagnostic Devices·233 affected·Dec 11, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended...
Diagnostic Devices·1,979 affected·Dec 10, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the ...
Diagnostic Devices·1,998 affected·Dec 6, 2012
High RiskFDA
Quidel Corporation
Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Diagnostic Devices·13,090 affected·Dec 3, 2012
RecallFDA
Siemens Healthcare Diagnostics
Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone...
Diagnostic Devices·742 affected·Nov 28, 2012
High RiskFDA
Philips Healthcare Inc.
Mobile Diagnostic X-Ray System with Digital Panel
Diagnostic Devices·220 affected·Nov 28, 2012
RecallFDA
Siemens Healthcare Diagnostics
Immunoradiometric assay.
Diagnostic Devices·831 affected·Nov 28, 2012
High RiskFDA
Roche Molecular Systems, Inc.
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Diagnostic Devices·335 affected·Nov 28, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Diagnostic Devices·2,976 affected·Nov 27, 2012
High RiskFDA
Ge Healthcare It
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagno...
Diagnostic Devices·498 affected·Nov 15, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 ...
Diagnostic Devices·100 affected·Nov 14, 2012
High RiskFDA
Leica Microsystems, Inc.
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for...
Diagnostic Devices·322 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro...
Diagnostic Devices·50 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in v...
Diagnostic Devices·250 affected·Nov 14, 2012
High RiskFDA
Ids (immunodiagnostic Systems Ltd.)
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for ...
Diagnostic Devices·675 affected·Nov 7, 2012
RecallFDA
Hemocue Ab
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its...
Diagnostic Devices·48 affected·Nov 7, 2012
High RiskFDA
Beckman Coulter Inc.
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (...
Diagnostic Devices·14,409 affected·Nov 5, 2012
RecallFDA
Ortho-clinical Diagnostics
VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantita...
Diagnostic Devices·1,464 affected·Nov 1, 2012
CriticalFDA
Philips Healthcare Inc.
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Diagnostic Devices·623 affected·Oct 30, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Digital Diagnost Stationary radiographic system
Diagnostic Devices·360 affected·Oct 30, 2012
High RiskFDA
Philips Healthcare Inc.
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital...
Diagnostic Devices·551 affected·Oct 25, 2012
High RiskFDA
Sekisui Diagnostics Llc
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Typ...
Diagnostic Devices·63 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scannin...
Diagnostic Devices·37 affected·Oct 24, 2012
RecallFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of ...
Diagnostic Devices·1,985 affected·Oct 10, 2012
High RiskFDA
Alfa Wassermann, Inc.
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ...
Diagnostic Devices·4,104 affected·Oct 10, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalo...
Diagnostic Devices·234 affected·Oct 9, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Cata...
Diagnostic Devices·2,440 affected·Oct 9, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determin...
Diagnostic Devices·19,310 affected·Oct 8, 2012
High RiskFDA
Ventana Medical Systems Inc
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCO...
Diagnostic Devices·54 affected·Sep 28, 2012
High RiskFDA
Ventana Medical Systems Inc
VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCO...
Diagnostic Devices·1,735 affected·Sep 28, 2012
High RiskFDA
Cellestis Inc
Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs...
Diagnostic Devices·29,690 affected·Sep 27, 2012
High RiskFDA
Cellestis Inc
VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: Qu...
Diagnostic Devices·309,400 affected·Sep 27, 2012
High RiskFDA
Elekta, Inc.
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply e...
Diagnostic Devices·300 affected·Sep 18, 2012
High RiskFDA
Becton Dickinson & Co.
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Diagnostic Devices·86 affected·Sep 18, 2012
High RiskFDA
Ge Healthcare It
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as...
Diagnostic Devices·748 affected·Sep 15, 2012
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level co...
Diagnostic Devices·22,954 affected·Sep 14, 2012
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The AB...
Diagnostic Devices·8,503 affected·Sep 14, 2012
High RiskFDA
Advandx Inc
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae ...
Diagnostic Devices·187 affected·Sep 14, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: ...
Diagnostic Devices·536 affected·Sep 12, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marke...
Diagnostic Devices·15,455 affected·Sep 11, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 7...
Diagnostic Devices·93 affected·Sep 6, 2012
High RiskFDA
Remel Inc
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit i...
Diagnostic Devices·50 affected·Aug 20, 2012
High RiskFDA
Remel Inc
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The ...
Diagnostic Devices·493 affected·Aug 20, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121...
Diagnostic Devices·240 affected·Aug 16, 2012