Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. SEBIA, FSCA-05-2024-01, CAPI 3 IMMUNOTYPING

   Er is ongewenste anti-IgG-activiteit waargenomen met het anti-Kappa antiserum. Als gevolg hiervan wordt op de Kappa-track een ...

   Waarschuwing | 30-05-2024

2. Agilent Technologies Singapore .International. Pte Ltd., Dako CoverStainer, Dako CoverStainer CPO

   It has come to our attention that the assembly supporting the weight of the lower front door in some cases may cause the ...

   Waarschuwing | 24-05-2024

3. HYPHEN BioMed, FSCA#37, ZYMUTEST™ Total Protein S (II)

   Following a customer complaint and to our preliminary investigation, we would like to inform you that the ZYMUTEST ™ Total ...

   Waarschuwing | 23-05-2024

4. Alere San Diego,FCA-00000283, Cholestech LDX Analyzer

   This letter is to inform you that Alere San Diego has recently revised the Cholestech LDX™ Battery label warning to include the ...

   Waarschuwing | 23-05-2024

5. Illumina, Inc., NextSeq 550Dx, MiSeqDx, NovaSeq 6000Dx instruments, the Illumina DRAGEN Server for NextSeq 550Dx, the Illumina DRAGEN Server v4, VeriSeq Onsite Server v2.

   While conducting routine cybersecurity analysis, Illumina’s Product Security Team identified an uncontrolled product security ...

   Waarschuwing | 23-05-2024

6. Beckman Coulter, 24019, DxI 9000 Access Immunoassay Analyzer

   Beckman Coulter heeft vastgesteld dat de DxI 9000 Access Immunoassay-analysator kalibratorwaarden accepteert die zijn gescand ...

   Waarschuwing | 07-05-2024

7. Cepheid, 24FAR003, Xpert Carba-R

   Vals-positieve patiënt testresultaten kunnen leiden tot onnodige contactvoorzorgsmaatregelen om verspreiding van de infectie te ...

   Waarschuwing | 03-05-2024

8. Leica Biosystems Nussloch GmbH, CN-251519, HistoCore Pegasus / HistoCore Pegasus Plus

   The overfilling of reagents by users, excess reagent carried from the basket during initial loading, or excessive reagent in the ...

   Waarschuwing | 23-04-2024

9. Stago, RC-24-0001, Star Max. Sta-R Evolution. Compact Max

   Stago has investigated and confirmed a potential risk of pipetting close to or into the packed red blood cells when using these ...

   Waarschuwing | 05-04-2024

10. Randox Laboratories Ltd, REC731, CALIBRATION SERUM LEVEL 3 (CAL 3)

    Randox Laboratories is erachter gekomen dat het anorganisch fosfaat in kalibratieserum niveau 3, CAL2351, een negatieve afwijking ...

    Waarschuwing | 04-04-2024