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  1. bioMérieux SA FCA 3204 - Etest® MBL MP/MPI 8/2 B30

    The bioMérieux UK subsidiary reported to the International Distribution Centre (IDC) that they had observed a non-conformity on ...

    Waarschuwing | 17-11-2016

  2. Hologic SCAR-01037 - ATEC Canister

    There have been reports of customers receiving ATEC canisters with cracked lids.  We wanted to notify you that Hologic is aware ...

    Waarschuwing | 08-11-2016

  3. Intuitive Surgical Inc 2955842-07/14/16-010-R - IS4000 EndoWrist Stapler 45, IS4000 EndoWrist Stapler 30, IS4000 EndoWrist Stapler 30 Curved-Tip

    This recall follows from a field failure where the stapler remained clamped on tissue, even when the Stapler Release Kit was ...

    Waarschuwing | 03-11-2016

  4. Teleflex Medical EIF-000093 - Mucosal Atomization Device (MAD)

    Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray. The ...

    Waarschuwing | 02-11-2016

  5. Trinity Biotech R019-16 - MicroTrak Syphilis TPHA

    Trinity Biotech has determined that there is a sensitivity performance issue with the MicroTrak® Syphilis TPHA products. Our ...

    Waarschuwing | 26-10-2016

  6. Siemens Healthcare GmbH MR03216S PM00056463 - Combi Dockable Table Neurosurgery

    We have reasons to believe that in some cases the Combi Dockable Table Neurosurgery may have not been properly manufactured. Due ...

    Waarschuwing | 11-10-2016

  7. Covidien LLC Clearify Visualization 10/16 - Clearify Visualization System

    This Field Safety Corrective Action (FSCA) is being conducted due to the potential for compromise of the package resulting in a ...

    Waarschuwing | 07-10-2016

  8. Vascular Solutions 2134812-09.20.2016-002R - Twin-Pass, Twin-Pass .023", and Twin-Pass RX Dual Access Catheters

    Upon investigation of Twin-Pass units, it’s been concluded there is a potential for excess manufacturing material to remain at ...

    Waarschuwing | 23-09-2016

  9. Roche Diagnostics CN-262866 - A1C-2 en A1CX2, Tina-quant, COBAS INTEGRA®

    Customers complained that individual c packs of Tina-quant HbA1c Gen. 2 and Tina-quant HbA1c Dx Gen. 2 reagent across multiple ...

    Waarschuwing | 22-09-2016

  10. Maquet CAPA 2016-010 - Accessory Adapter

    As part of our Post Market Surveillance one case has been reported to Maquet GmbH in which a Head Rest was levered out of the ...

    Waarschuwing | 09-09-2016