Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. DNA Genotek, 200018182, ORAcollect DNA / ORAcollect RNA / ORAcollect Dx

   As a result, in a small subset of products, the amount of available stabilizing liquid may be lower than expected.

   Waarschuwing | 20-04-2022

2. Radiometer FAN 915-420 - PICO50 Arterial Blood Sampler

   Radiometer has become aware of an issue with PICO50 Arterial Blood Sampler. The issue relates to the sterile barrier system for ...

   Waarschuwing | 20-04-2022

3. Helena Biosciences NC476 - SAS Free Kappa_Lambda IEF Kit

   Further to customer feedback regarding the performance of the SAS Free Kappa IEF Kit: REF 102208 and SAS Free Lambda IEF Kit: REF ...

   Waarschuwing | 20-04-2022

4. Abbott GmbH FA24MAR2022 - Alinity i Homocysteine Reagent Kit

   Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control ...

   Waarschuwing | 19-04-2022

5. Abbott Molecular, Inc., FSN-FA-AM-SEP2021-260 & FA-AM-SEP2021-260v2, Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kit

   This is a follow-up to Urgent Field Safety Notice FA-AM-SEP2021-260 regarding potential false positive results when using Alinity ...

   Waarschuwing | 08-04-2022

6. Illumina, QI-000509, NextSeq 550Dx

   Illumina heeft een probleem vastgesteld dat kortsluiting kan veroorzaken in de behuizing van het instrument.

   Waarschuwing | 31-03-2022

7. Siemens Healthcare Diagnostics AIMC 22-03 - Atellica® Solution and ADVIA Centaur® Systems

   Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens ...

   Waarschuwing | 28-03-2022

8. Siemens Healthcare Diagnostics POC 22-002 - Atellica® UAS 800 Urine Sediment Analyzer & Atellica® 1500 Automated Urinalysis System

   Siemens Healthcare Diagnostics has confirmed that the door gas spring which holds the analyzer door open is failing before its ...

   Waarschuwing | 28-03-2022

9. Abbott Molecular FA-AM-MAR2022-269 - Alinity m HBV AMP Kit

   Abbott has received reports of falsely elevated results when using the Alinity m HBV AMP Kit. Data analysis has determined that ...

   Waarschuwing | 28-03-2022

10. SENTINEL FSCA 01/2022 - CALiaGOLD Control Set

    An accuracy issue using Sentinel CALiaGold® Control Set REF 1151200 has been encountered, when testing the control material, ...

    Waarschuwing | 28-03-2022