Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Microgenics Corporation, Application Sheets

   During an internal assessment we found that Application Sheets provided by Microgenics for expanded use of some Assays are ...

   Waarschuwing | 16-05-2017

2. Field Safety Notice: BRAHMS GmbH, part of Thermo Fisher Scientific, B•R•A•H•M•S anti-Tgn RIA

   During additional quality control testing we observed for B•R•A•H•M•S anti-Tgn RIA lot 127137, lot 134428 and lot 141439 an ...

   Waarschuwing | 15-05-2017

3. Field Safety Notice: BÜHLMANN Laboratories AG, CALEX® Cap

   This Field Safety notice provides additional technical information about the expected calprotectin result agreement between stool ...

   Waarschuwing | 21-04-2017

4. Field Safety Notice: Waters Corporation - ACQUITY UPLC Sample Organizer

   Waters Corporation start deze terugroeping omdat er een mogelijkheid bestaat dat een interne zekeringsafscherming ontbrandt, wat ...

   Waarschuwing | 10-04-2017

5. Field Safety Notice: bioMérieux - Etest OX 256

   Based on QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST® OX 256 (OXACILLIN) Foam packaging (Ref. ...

   Waarschuwing | 28-03-2017

6. Field Safety Notice: bioMérieux - VITEK® MS V2.0 and V3.0

   It has been identified that the VITEK® MS system could give, in specific conditions, an incorrect identification result if the ...

   Waarschuwing | 10-03-2017

7. Field Safety Notice: Phadia_Thermo Fisher - EliA and ImmunoCAP Specific IgA/IgG Sample Diluent

   There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles in the below mentioned products and ...

   Waarschuwing | 07-02-2017

8. Field Safety Notice: Roche - Elecsys TSH and PTH assay

   We regret to inform you that in case the Elecsys PTH (1-84) assay lot 185522 (expiry date May 2016) and Elecsys TSH assay lot ...

   Waarschuwing | 03-02-2017

9. 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

10. 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