Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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. 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

3. 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

4. bioMérieux SA FSCA 3108 - Campylosel agar

   Due to the referenced issue there is a potential to have a misinterpretation of the results related to the growth of Enterobacter ...

   Waarschuwing | 02-08-2016

5. Alere CAPA-00000981 - Alere Afinion CRP

   Het bewaren van de bovengenoemde loten op kamertemperatuur (15-25 °C) heeft een invloed op het product. Het gebruik van de ...

   Waarschuwing | 22-07-2016

6. Roche Diagnostics GmbH CN-116536 (GC-0791409) and CN-253267 - cobas b123 <3> POC system, cobas b123 <4> POC syst bilirubine

   We have become aware of an issue that may lead to erroneously low results for neonatal bilirubin on cobas b 123 systems in rare ...

   Waarschuwing | 06-07-2016

7. Siemens Healthcare Diagnostics LAI 16-02 - Aptio Automation System,StreamLAB Analytical Workc

   Siemens Healthcare Diagnostics is issuing an Urgent Field Safety Notice for the buckets (Model 4464-R) (SMN 10723514: Hettich ...

   Waarschuwing | 31-05-2016

8. Siemens DC16-03 - Vista Enzyme 2 calibrator and Dimension Enz II cal 529

   Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is ...

   Waarschuwing | 31-05-2016

9. Check-Points Health CAPA 16-0055 - Check-Direct CPE Screen for BD MAX

   It has come to our attention that the expiry date on the kit is not correct. The correct expiry date is 2016-07 and not 2016-11 ...

   Waarschuwing | 25-05-2016

10. MDSS 1627497-2016-00001-R; MDSS ref.: IVD16.035 - Histoplasma Yeast CF Antigen Dilute

    As part of post-market surveillance activities, the above device was found to have bacterial contamination. We are aware of one ...

    Waarschuwing | 09-05-2016