Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Accumetrics Inc
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a...
Diagnostic Devices·576 affected·Feb 13, 2014
High RiskFDA
Biomerieux Inc
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Diagnostic Devices·471 affected·Feb 10, 2014
High RiskFDA
Ge Healthcare, Llc
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to ...
Diagnostic Devices·3,062 affected·Feb 7, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic...
Diagnostic Devices·37 affected·Feb 7, 2014
High RiskFDA
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 Medici...
Diagnostic Devices·3,062 affected·Feb 7, 2014
High RiskFDA
Leica Biosystems Imaging, Inc.
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ...
Diagnostic Devices·78 affected·Feb 7, 2014
High RiskFDA
Lin-zhi International Inc
Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as pot...
Diagnostic Devices·216 affected·Feb 6, 2014
High RiskFDA
Lin-zhi International Inc
Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as pot...
Diagnostic Devices·130 affected·Feb 6, 2014
High RiskFDA
Alere San Diego, Inc.
Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devi...
Diagnostic Devices·305 affected·Feb 5, 2014
High RiskFDA
Focus Diagnostics Inc
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV v...
Diagnostic Devices·2,175 affected·Feb 4, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chem...
Diagnostic Devices·284 affected·Jan 29, 2014
High RiskFDA
Carestream Health Inc.
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 1460...
Diagnostic Devices·347 affected·Jan 24, 2014
High RiskFDA
Carestream Health Inc.
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France ...
Diagnostic Devices·347 affected·Jan 24, 2014
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D C...
Diagnostic Devices·1,554 affected·Jan 15, 2014
High RiskFDA
Instrumentarium Dental, Palodex Group Oy
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental i...
Diagnostic Devices·101 affected·Jan 14, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in ...
Diagnostic Devices·64 affected·Jan 9, 2014
High RiskFDA
Veridex, Llc
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope,...
Diagnostic Devices·19 affected·Jan 8, 2014
High RiskFDA
Siemens Healthcare Diagnostics
IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro...
Diagnostic Devices·5,953 affected·Dec 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics
IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare D...
Diagnostic Devices·892 affected·Dec 20, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determinati...
Diagnostic Devices·1,294 affected·Dec 18, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determinat...
Diagnostic Devices·1,294 affected·Dec 18, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to ...
Diagnostic Devices·816 affected·Dec 12, 2013
RecallFDA
Advandx, Inc.
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gra...
Diagnostic Devices·49 affected·Dec 11, 2013
High RiskFDA
Becton Dickinson & Co.
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The inst...
Diagnostic Devices·2 affected·Dec 9, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT ...
Diagnostic Devices·386 affected·Dec 4, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quanti...
Diagnostic Devices·1 affected·Nov 26, 2013
High RiskFDA
Carestream Health, Inc.
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator consol...
Diagnostic Devices·493 affected·Nov 25, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Lin...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling L...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needl...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blo...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) A...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Lue...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip s...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Smiths Medical Asd, Inc.
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) ...
Diagnostic Devices·0 affected·Nov 22, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for ...
Diagnostic Devices·376 affected·Nov 20, 2013
High RiskFDA
Instrumentation Laboratory Co.
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Diagnostic Devices·84,561 affected·Nov 15, 2013
High RiskFDA
Instrumentation Laboratory Co.
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Diagnostic Devices·80,319 affected·Nov 15, 2013
High RiskFDA
Instrumentation Laboratory Co.
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Diagnostic Devices·6,504 affected·Nov 15, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening ...
Diagnostic Devices·2,874 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations fo...
Diagnostic Devices·164 affected·Nov 8, 2013
High RiskFDA
Beckman Coulter Inc.
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative...
Diagnostic Devices·1,961 affected·Nov 8, 2013
High RiskFDA
Qualigen Inc
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack ...
Diagnostic Devices·6 affected·Nov 8, 2013
High RiskFDA
Qualigen Inc
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a pa...
Diagnostic Devices·18 affected·Nov 8, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Diagnostic Devices·1,920 affected·Oct 25, 2013
CriticalFDA
Medtronic Vascular
THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction an...
Diagnostic Devices·1,205 affected·Oct 21, 2013