Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
C.r. Bard, Inc.
Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connect...
Diagnostic Devices·4,800 affected·Feb 27, 2018
High RiskFDA
C.r. Bard, Inc.
Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connecto...
Diagnostic Devices·3,200 affected·Feb 27, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Diagnostic Devices·0 affected·Feb 26, 2018
High RiskFDA
Hycor Biomedical Inc
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either ...
Diagnostic Devices·207 affected·Feb 21, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Diagnostic Devices·10,310,443 affected·Feb 21, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Diagnostic Devices·3,322 affected·Feb 13, 2018
High RiskFDA
Stanbio Laboratory, Lp
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156...
Diagnostic Devices·686 affected·Feb 13, 2018
High RiskFDA
Hyphen Biomed
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype...
Diagnostic Devices·60 affected·Feb 5, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic t...
Diagnostic Devices·6,000 affected·Jan 30, 2018
CriticalFDA
Biomerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card ...
Diagnostic Devices·13,961,320 affected·Jan 26, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Diagnostic Devices·42 affected·Jan 26, 2018
High RiskFDA
Hologic, Inc
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result i...
Diagnostic Devices·103 affected·Jan 20, 2018
CriticalFDA
Beckman Coulter Inc.
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for i...
Diagnostic Devices·3,115 affected·Jan 12, 2018
High RiskFDA
Tecan Us, Inc.
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro ...
Diagnostic Devices·870 affected·Jan 12, 2018
RecallFDA
Clinical Diagnostic Systems
VITROS Immunodiagnostic Products TSH Reagent Pack
Diagnostic Devices·5,470 affected·Jan 11, 2018
RecallFDA
Diamedix Corporation
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Diagnostic Devices·505 affected·Jan 5, 2018
RecallFDA
Diamedix Corporation
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Diagnostic Devices·147 affected·Jan 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography syst...
Diagnostic Devices·22 affected·Jan 5, 2018
High RiskFDA
Biomerieux, Inc.
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automa...
Diagnostic Devices·1,866 affected·Jan 4, 2018
High RiskFDA
Toshiba American Medical Systems Inc
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start ...
Diagnostic Devices·162 affected·Jan 4, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Roche Diagnostics Corporation
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Diagnostic Devices·35,111 affected·Jan 2, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Diagnostic Devices·0 affected·Jan 2, 2018
High RiskFDA
Roche Diagnostics Corporation
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3...
Diagnostic Devices·47 affected·Dec 22, 2017
RecallFDA
Quantimetrix Corporation
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is ...
Diagnostic Devices·20 affected·Dec 21, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Diagnostic Devices·72,730 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Diagnostic Devices·71,640 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Diagnostic Devices·1,980 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
Diagnostic Devices·3,122 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Diagnostic Devices·18 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Diagnostic Devices·358 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Diagnostic Devices·5,040 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Diagnostic Devices·20 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
Diagnostic Devices·748 affected·Dec 19, 2017
High RiskFDA
Phadia Us Inc
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measu...
Diagnostic Devices·950 affected·Dec 18, 2017
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The ...
Diagnostic Devices·9 affected·Dec 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for...
Diagnostic Devices·0 affected·Nov 27, 2017
High RiskFDA
Medica Corporation
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use...
Diagnostic Devices·392 affected·Nov 21, 2017
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Diagnostic Devices·10 affected·Nov 21, 2017
High RiskFDA
Phadia Ab
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and El...
Diagnostic Devices·2,307 affected·Nov 20, 2017
High RiskFDA
Alere San Diego, Inc.
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solutio...
Diagnostic Devices·2,940 affected·Nov 14, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stim...
Diagnostic Devices·989 affected·Nov 9, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Diagnostic Devices·1,385 affected·Nov 8, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Diagnostic Devices·134 affected·Nov 8, 2017