Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Beckman Coulter, Inc FA-000176 various regents

   Beckman Coulter heeft geconstateerd dat N-acetyl-p-benzoquinonimine (NAPQI), een metaboliet van acetaminofen (paracetamol), ...

   Waarschuwing | 05-09-2019

2. Roche Diagnostics GmbH IO-0000166 (SBN-CPS-2019-019) IGG-2 (Tina-quant IgG Gen.2)

   As CSF samples have lower concentrations than serum samples, due to carry over, a CSF sample might yield discrepant higher ...

   Waarschuwing | 03-09-2019

3. Randox Laboratories, REC407, Rheumatoid Factor Standard, Liquid Protein Calibra

   Randox is conducting a Device Modification for Rheumatoid Factor Standard and Liquid Protein Calibrator for the lots specified in ...

   Waarschuwing | 30-08-2019

4. Randox Laboratories Ltd - REC395 - Calibration Serum Level 3

   Randox have realigned the RX Analyser Series calibration t argets by 10% for AST and 9% for ALT in line with the Mean of All ...

   Waarschuwing | 05-07-2019

5. SENTINEL CH. SpA - 02/2019 - Lithium, Alinity c Lithium Reagent Kit

   The purpose of this communication is to inform of an additional SmartWash parameter for the MULTIGENT Lithium reagent, List ...

   Waarschuwing | 28-06-2019

6. RSR Limited - RSR/06/2019/01 - RiaRSR™ AChRAb

   This field safety notice is to inform you that the multiple lots of RiaRSR™ AChRAb may demonstrate high background  counts.

   Waarschuwing | 06-06-2019

7. bioMerieux Inc, FSCA 4360, Chocolat PolyViteX (PVX)

   We hebben klachten ontvangen van klanten over een afwijkende groei (beperkt of afwezig) voor de volgende stammen:...

   Waarschuwing | 23-05-2019

8. Randox Laboratories, REC398, HUMAN ASSAYED MULTI-SERA Level 2

   Randox has identified a labelling error in the value sheet for Human Assayed Controls Level 2 lots 1306UN, 1308UN and 1309UN.

   Waarschuwing | 23-05-2019

9. Roche Diagnostics, CN-431825, IGA-2 (Tina-quant IgA Gen.2)

   Internal investigations of the affected c packs revealed contamination of R1 with R3 (containing antibody).

   Waarschuwing | 22-05-2019

10. Axis-Shield 077565 - Alere NT-proBNP Control_Alere NT-proBNP Calibrator

    All of the lots listed above demonstrate a time dependent, stability drift in results returned from NT-proBNP testing on both the ...

    Waarschuwing | 25-04-2019