Category

Diagnostic Devices Recalls

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

1,863 recalls
RecallFDA
Diagnostic Hybrids, Inc.
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 comple...
Diagnostic Devices·107 affected·Nov 3, 2015
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific...
Diagnostic Devices·23 affected·Oct 30, 2015
High RiskFDA
Ameditech Inc
10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of mul...
Diagnostic Devices·200 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immuno...
Diagnostic Devices·7,482 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 6096...
Diagnostic Devices·1,220 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative...
Diagnostic Devices·220 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are o...
Diagnostic Devices·150 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative d...
Diagnostic Devices·960 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative...
Diagnostic Devices·3,574 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative dete...
Diagnostic Devices·320 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are...
Diagnostic Devices·100 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple...
Diagnostic Devices·70,364 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abus...
Diagnostic Devices·160 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are ...
Diagnostic Devices·300 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12...
Diagnostic Devices·1,172 affected·Oct 20, 2015
High RiskFDA
Beckman Coulter Inc.
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Diagnostic Devices·11,406 affected·Oct 13, 2015
RecallFDA
Becton, Dickinson And Company, Bd Biosciences
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-c...
Diagnostic Devices·120 affected·Sep 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in...
Diagnostic Devices·3,601 affected·Sep 30, 2015
High RiskFDA
Sentinel Ch Spa
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro...
Diagnostic Devices·765 affected·Sep 22, 2015
High RiskFDA
Lifehealth, Llc
CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intende...
Diagnostic Devices·4,659 affected·Sep 16, 2015
High RiskFDA
Lifehealth, Llc
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended...
Diagnostic Devices·1,735 affected·Sep 16, 2015
High RiskFDA
Natus Neurology Inc
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without sy...
Diagnostic Devices·101 affected·Sep 11, 2015
High RiskFDA
Biocare Medical, Llc
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted...
Diagnostic Devices·151 affected·Sep 8, 2015
High RiskFDA
Dako North America Inc.
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link...
Diagnostic Devices·300 affected·Sep 4, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Op...
Diagnostic Devices·756 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
Diagnostic Devices·55 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonanc...
Diagnostic Devices·215 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic im...
Diagnostic Devices·97 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnost...
Diagnostic Devices·350 affected·Aug 31, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions wi...
Diagnostic Devices·449 affected·Aug 26, 2015
High RiskFDA
Carestream Health Inc
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radio...
Diagnostic Devices·76 affected·Aug 7, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging syste...
Diagnostic Devices·1,183 affected·Jul 31, 2015
High RiskFDA
Beckman Coulter Inc.
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patie...
Diagnostic Devices·3,084 affected·Jul 30, 2015
High RiskFDA
Beckman Coulter Inc.
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in pati...
Diagnostic Devices·2,130 affected·Jul 30, 2015
High RiskFDA
Beckman Coulter Inc.
AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patie...
Diagnostic Devices·3,355 affected·Jul 30, 2015
High RiskFDA
Beckman Coulter Inc.
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in hum...
Diagnostic Devices·3,035 affected·Jul 28, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ...
Diagnostic Devices·466 affected·Jul 27, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for...
Diagnostic Devices·1,655 affected·Jul 23, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine s...
Diagnostic Devices·399 affected·Jul 22, 2015
High RiskFDA
Neuro Kinetics, Inc.
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic...
Diagnostic Devices·45 affected·Jul 21, 2015
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhe...
Diagnostic Devices·362 affected·Jul 17, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is...
Diagnostic Devices·32,165 affected·Jul 15, 2015
High RiskFDA
Sedecal S.a.
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on ...
Diagnostic Devices·361 affected·Jul 13, 2015
High RiskFDA
Hardy Diagnostics
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Stora...
Diagnostic Devices·2,820 affected·Jul 9, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·44 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·13 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomo...
Diagnostic Devices·2 affected·Jul 1, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and...
Diagnostic Devices·1,032 affected·Jun 30, 2015