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
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in...
Diagnostic Devices·2,840 affected·Jul 25, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinica...
Diagnostic Devices·929 affected·Jul 19, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical u...
Diagnostic Devices·311 affected·Jul 19, 2013
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical u...
Diagnostic Devices·486 affected·Jul 19, 2013
High RiskFDA
Assuramed
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Prod...
Diagnostic Devices·10 affected·Jul 16, 2013
High RiskFDA
Assuramed
ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATE...
Diagnostic Devices·1 affected·Jul 16, 2013
High RiskFDA
Hemocue Ab
HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay...
Diagnostic Devices·10,356 affected·Jul 16, 2013
RecallFDA
Celera Corporation
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 500033...
Diagnostic Devices·43 affected·Jul 12, 2013
RecallFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating th...
Diagnostic Devices·265 affected·Jun 28, 2013
High RiskFDA
Siemens Healthcare Diagnostics
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/...
Diagnostic Devices·24,361 affected·Jun 26, 2013
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tes...
Diagnostic Devices·20 affected·Jun 17, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 4...
Diagnostic Devices·12,384 affected·Jun 14, 2013
High RiskFDA
Biomerieux Inc
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part ...
Diagnostic Devices·12,384 affected·Jun 14, 2013
CriticalFDA
Ge Healthcare, Llc
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system i...
Diagnostic Devices·50 affected·Jun 13, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Me...
Diagnostic Devices·571 affected·Jun 13, 2013
High RiskFDA
Ge Healthcare It
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare...
Diagnostic Devices·623 affected·Jun 11, 2013
High RiskFDA
Philips Healthcare Inc.
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile d...
Diagnostic Devices·240 affected·Jun 11, 2013
High RiskFDA
Ortho-clinical Diagnostics
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The C...
Diagnostic Devices·0 affected·Jun 6, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnost...
Diagnostic Devices·7,470 affected·Jun 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Diagnostic Devices·401 affected·Jun 5, 2013
High RiskFDA
Beckman Coulter Inc.
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5...
Diagnostic Devices·76 affected·Jun 3, 2013
High RiskFDA
Terumo Medical Corporation
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the i...
Diagnostic Devices·20 affected·May 30, 2013
High RiskFDA
Beckman Coulter Inc.
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s...
Diagnostic Devices·3,353 affected·May 28, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. ...
Diagnostic Devices·776 affected·May 20, 2013
High RiskFDA
Sysmex America Inc
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo...
Diagnostic Devices·193 affected·May 15, 2013
High RiskFDA
Tosoh Smd Inc
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are dispo...
Diagnostic Devices·11,309 affected·May 15, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
Diagnostic Devices·198 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determ...
Diagnostic Devices·3,302 affected·May 14, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Diagnostic Devices·99 affected·May 14, 2013
High RiskFDA
Life Technologies Corporation
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use...
Diagnostic Devices·15 affected·May 13, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormon...
Diagnostic Devices·33,506 affected·May 10, 2013
RecallFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use...
Diagnostic Devices·4,257 affected·May 9, 2013
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use o...
Diagnostic Devices·236,364 affected·May 9, 2013
High RiskFDA
Ortho-clinical Diagnostics
ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use w...
Diagnostic Devices·31 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Pro...
Diagnostic Devices·101 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qua...
Diagnostic Devices·381 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quant...
Diagnostic Devices·69 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, an...
Diagnostic Devices·98 affected·May 6, 2013
High RiskFDA
Remel Inc
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Rem...
Diagnostic Devices·109 affected·May 2, 2013
High RiskFDA
Wako Life Sciences, Inc.
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan ...
Diagnostic Devices·36 affected·Apr 30, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure ...
Diagnostic Devices·13,751 affected·Apr 25, 2013