Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. LDN Labor Diagnostika Nord GmbH & Co. KG, DE/0000040010, Androstanediol-Glucuronide ELISA

   For the product AA E-1500 Androstanediol Glucuronides ELISA Lot 230083( it has been detected that the standards D (AA E-1504 Lot ...

   Waarschuwing | 08-12-2023

2. QuidelOrtho (Ortho Clinical Diagnostics Inc), CL2023-257, ORTHO VISION and VISION Max Analyzers for BioVue

   The wash protocol for ORTHO Sera Anti-Jkb on the ORTHO VISION / VISION Max BioVue Analyzer does not sufficiently clean the ...

   Waarschuwing | 23-11-2023

3. EPOCAL, POC 24-001, epoc NXS Host

   The epoc NXS Host was confirmed to display incorrect results in Test History, after printing, or when viewed on a Data Manager ...

   Waarschuwing | 17-11-2023

4. Siemens Healthcare Diagnostics Inc., RAPIDPoint 500 Systems Measurement Cartridge

   Siemens Healthcare Diagnostics Inc. has confirmed an issue with RAPIDPoint 500 Systems Measurement Cartridges (with lactate).

   Waarschuwing | 17-11-2023

5. BioFire Diagnosticss, LLC, FSCA 5761-1, BIOFIRE FILMARRAY TORCH

   When turning on BIOFIRE TORCH systems, arcing inside of the power switch may result in carbon build-up on the switch contacts. ...

   Waarschuwing | 10-11-2023

6. Illumina, Inc., FSN-QI – 00632, NextSeq 550Dx Instrument / MiSeq Dx Instrument

   Illumina heeft een kwetsbaarheid in de cybersecurity aangetroffen die van toepassing is op de Local Run Manager (LRM)-software in ...

   Waarschuwing | 10-11-2023

7. QuidelOrtho (Ortho Clinical Diagnostics Inc), CL2023-250, ORTHO VISION and VISION Max Analyzers for BioVue

   During an internal review, QuidelOrtho identified that Test ID 10023 included a calculated Rh (Anti-D or RhD) Interpretation ...

   Waarschuwing | 09-11-2023

8. Abbott Molecular, Inc., FA-AM-OCT2023-293, Alinity m HCV AMP Kit

   Abbott has identified an increase in potential for reactive negative controls as well as separate instances of false positive ...

   Waarschuwing | 09-11-2023

9. Instrumentation Laboratory Co., FSCA 2023-007-C, ACL TOP Family 50 Series and ACL TOP 970 CL

   Deze notificatie is bedoeld om uw laboratorium te informeren over een zeldzame potentiële monster misidentificatie onder ...

   Waarschuwing | 09-11-2023

10. Abbott Diagnostics Scarborough, Inc., 2023 09, ID NOW™ Instrument

    Bij gebruik van de huidige versie van de ID NOW-software, versie 7.0, hebben gebruikers de mogelijkheid om de ID NOW COVID-19 ...

    Waarschuwing | 02-11-2023