Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Roche Diagnostics GmbH - CN-438868 - cobas p507 post-analytical unit

   The Tray Input Flap on the cobas p 501 and cobas p 701 post-analytical units has the potential to become unsecured from the ...

   Waarschuwing | 20-03-2019

2. Field Safety Notice: SIS Medical, BEO NC PTCA Catheters

   In SIS Medical's internal trending we have noted an increased complaint rate with balloon deflation difficulties of device lots ...

   Waarschuwing | 03-08-2017

3. Beckman Coulter, 24024, DxI 9000 Access Immunoassay Analyzer

   Beckman Coulter heeft vastgesteld dat wanneer een DxI 9000 Access Immunoassay Analyzer is aangesloten op een Laboratory ...

   Waarschuwing | 11-06-2024

4. 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

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. Cepheid, 24FAR003, Xpert Carba-R

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

   Waarschuwing | 03-05-2024

7. 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

8. Siemens Healthcare Diagnostics Inc., ACHC 24-03, Atellica CH Iron3

   Siemens Healthineers has confirmed the potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica® CH and ...

   Waarschuwing | 04-04-2024

9. Randox Laboratories Ltd., REC718, CYSTATIN C CALIBRATOR (CYSC CAL)

   Randox Laboratories is erachter gekomen dat de Cystatin C Calibrator uit de CYS 2699-serie een negatieve afwijking vertoont in ...

   Waarschuwing | 28-03-2024

10. Life Technologies Holdings Pte Ltd., PR# 756842, on PGM™ Dx Instrument System

    This communication is to inform you that Thermo Fisher Scientific has recently completed penetration testing on the Torrent ...

    Waarschuwing | 28-03-2024