Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Abbott Laboratories, FA01MAY2019, ARCHITECT c4000 / c8000 / c16000 Mixer

   There is the potential for the mixer blade, attached to the mixer with a screw and nut, to separate from the mixer.

   Waarschuwing | 01-05-2019

2. Ortho Clinical Diagnostics CL2019-090 - VITROS Chemistry Products CK Slides

   Ortho Clinical Diagnostics determined that VITROS CK Slides do not meet the current on-analyzer stability time of < 1 week when ...

   Waarschuwing | 10-04-2019

3. STANDARD DIAGNOSTICS, FA18001, SD BIOLINE Chikungunya IgM

   Standard Diagnostic, Inc. heeft een klacht ontvangen dat de gevoeligheid van de SD BIOLINE chikungunyatest lager is dan ...

   Waarschuwing | 31-03-2019

4. BÜHLMANN Laboratories AG, 2019.01, IBDoc Portal

   Een fout in het uploaden van de testresultaten naar de IBDoc® Portal voor uw patiënt(en) is [n] keer voorgekomen

   Waarschuwing | 21-03-2019

5. Roche, CN-430526/CN-426138, ALBP - Albumin BCP

   One affiliate complained about a particular delivery to the customer site for lot 35651401, where several reagent cassettes were ...

   Waarschuwing | 05-03-2019

6. GeneOhm Sciences Canada Inc - BDDS-19-1405 - BD MAX™ Enteric Bacterial Panel

   BD verricht een corrigerende actie in verband met de veiligheid in het veld voor twee Lotnummers (vermeld in tabel 1 hieronder) ...

   Waarschuwing | 08-02-2019

7. Phadia, EliA anti-TSH-R Well

   A malfunction of EliA anti-TSH-R Well Carriers 14-5639-01 in lot 0014 has been discovered.

   Waarschuwing | 22-01-2018

8. Beckman Coulter, FA-31978, Aquios

   When AQUIOS CL systems are connected to a Laboratory Information System (LIS), the system may duplicate sample requests leading ...

   Waarschuwing | 28-09-2017

9. Field Safety Notice: Beckman Coulter, Access BR Monitor

   Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de sécurité du ...

   Waarschuwing | 12-09-2017

10. Field Safety Notice: Sysmex - Fluorocell PLT

    Unfortunately it has come to our attention that Sysmex haematology IVD reagent Fluorocell PLT might participate in reporting ...

    Waarschuwing | 28-08-2017