Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures...
Diagnostic Devices·586 affected·Jun 30, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemi...
Diagnostic Devices·6,801,375 affected·Jun 30, 2015
High RiskFDA
Remel Inc
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal ...
Diagnostic Devices·4,420 affected·Jun 30, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculi...
Diagnostic Devices·900 affected·Jun 26, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Escul...
Diagnostic Devices·100 affected·Jun 26, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: ...
Diagnostic Devices·730 affected·Jun 26, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bil...
Diagnostic Devices·5,940 affected·Jun 26, 2015
High RiskFDA
Agfa Healthcare Corp.
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface ...
Diagnostic Devices·2 affected·Jun 26, 2015
High RiskFDA
Nidek Inc
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.0...
Diagnostic Devices·3,836 affected·Jun 15, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system ...
Diagnostic Devices·4,053 affected·Jun 12, 2015
High RiskFDA
Abbott Laboratories
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only....
Diagnostic Devices·5 affected·Jun 11, 2015
High RiskFDA
Volcano Corporation
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blo...
Diagnostic Devices·162 affected·Jun 4, 2015
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is inte...
Diagnostic Devices·1,445 affected·Jun 4, 2015
High RiskFDA
Tecan Us, Inc.
Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector opt...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microp...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate rea...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Tecan Us, Inc.
Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injecto...
Diagnostic Devices·868 affected·May 29, 2015
High RiskFDA
Ptw-freiburg
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic rad...
Diagnostic Devices·242 affected·May 27, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for us...
Diagnostic Devices·6,255 affected·May 7, 2015
RecallFDA
Biocare Medical, Llc
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclon...
Diagnostic Devices·19 affected·May 6, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. Fo...
Diagnostic Devices·17 affected·May 6, 2015
High RiskFDA
Richard-allan Scientific Company
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A ...
Diagnostic Devices·506 affected·Apr 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic...
Diagnostic Devices·133 affected·Apr 13, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management f...
Diagnostic Devices·2,387 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample ...
Diagnostic Devices·2,387 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management fo...
Diagnostic Devices·255 affected·Apr 6, 2015
High RiskFDA
Medtest Holdings, Inc.
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H757...
Diagnostic Devices·13 affected·Apr 3, 2015
High RiskFDA
Mela Sciences, Inc.
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Diagnostic Devices·65 affected·Apr 2, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dime...
Diagnostic Devices·17,801 affected·Apr 2, 2015
High RiskFDA
Diamedix Corporation
Diamedix Is-CMV IgG Test Kit
Diagnostic Devices·150 affected·Mar 26, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activ...
Diagnostic Devices·27,501 affected·Mar 25, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic A...
Diagnostic Devices·2,558 affected·Mar 23, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
Diagnostic Devices·7,814 affected·Mar 23, 2015
High RiskFDA
Bd Biosciences, Systems & Reagents
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Diagnostic Devices·9 affected·Mar 23, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended...
Diagnostic Devices·62 affected·Mar 23, 2015
High RiskFDA
Sedecal Usa, Inc.
Sedecal SA Mobile Diagnost w DR x-ray system
Diagnostic Devices·145 affected·Mar 23, 2015
High RiskFDA
Axis-shield Diagnostics, Ltd.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (D...
Diagnostic Devices·52 affected·Mar 20, 2015
High RiskFDA
Diasorin Inc.
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro ...
Diagnostic Devices·451 affected·Mar 16, 2015
High RiskFDA
Focus Diagnostics Inc
STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
Diagnostic Devices·300 affected·Mar 15, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
Diagnostic Devices·40 affected·Mar 13, 2015
CriticalFDA
Lusys Laboratories, Inc.
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
Diagnostic Devices·20 affected·Mar 13, 2015
RecallFDA
Pointe Scientific, Inc.
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of ...
Diagnostic Devices·7,545 affected·Mar 13, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD)...
Diagnostic Devices·132 affected·Mar 9, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·125 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst...
Diagnostic Devices·11 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging...
Diagnostic Devices·71 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging syst...
Diagnostic Devices·10 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·39 affected·Mar 6, 2015