Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Abbott Diagnostics FA16MAY2019 - ARCHITECT Assays

   The purpose of this letter is to inform you of an update to the REAGENTS and SPECIMEN COLLECTION AND HANDLING/ PREPARATION FOR ...

   Waarschuwing | 16-05-2019

2. Arkray Afc-fsca-2019-001 - AUTION HYBRID AU-4050

   Regarding the Fully Automated Integrated Urine Analyzer AUTION HYBRID AU4050, it was found that incorrect patient information is ...

   Waarschuwing | 09-05-2019

3. Beckman Coulter FA-000046 - Access Immunoassay Systems

   Beckman Coulter heeft de mogelijke interferentie-effecten van biotine (maximaal 1200 ng/ml) op alle biotine-gemedieerde ...

   Waarschuwing | 03-05-2019

4. Abbott Laboratories, FA01MAY2019, ARCHITECT c4000 / c8000 / c16000 Mixer

   There is the potential for the mixer blade, attached to the mixer with a screw and nut, to separate from the mixer.

   Waarschuwing | 01-05-2019

5. Bio-Rad_DiaMed GmbH FSCA 002-19 - IH-QC1

   Recently we have been made aware that the anti-D (RH1) less than 0.05 ID/ml contained in the IH-QC1 has given weaker reactions ...

   Waarschuwing | 29-04-2019

6. 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

7. Linkage Biosciences, MW 19-001, SureTyper Software

   When a session is opened in SureTyper v 6.0.0 for the first time, the software is not detecting the instrument that the raw data ...

   Waarschuwing | 16-04-2019

8. Thermo Fisher PO5133A.2635614 - Oxoid Bacillus Cereus Medium (MYP)

   An investigation has confirmed that Bacillus Cereus Medium (MYP), PO5133A, lot 2635614 has been incorrectly labelled. The outer ...

   Waarschuwing | 11-04-2019

9. Ortho Clinical Diagnostics CL2019-090 - VITROS Chemistry Products CK Slides

   Ortho Clinical Diagnostics determined that VITROS CK Slides do not meet the current on-analyzer stability time of < 1 week when ...

   Waarschuwing | 10-04-2019

10. Quidel FCA-001-19 - Triage TOX Drug Screen Control 1

    Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed ...

    Waarschuwing | 09-04-2019