Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Radiometer Medical ApS, FSN-2021-10-07, D513 Disposable Waste Container

   Radiometer has become aware of a potential issue with the D513 Disposable waste container for the ABL800 analyzers (details ...

   Waarschuwing | 28-10-2021

2. Leica Biosystems Newcastle Ltd, FSN-2021-10-18, BOND™ Ready-to-Use Primary Antibody CDX2 (EP25)

   Leico Biosystems recently became aware that the effected device mentioned above may not perform as specified in the IFU. We have ...

   Waarschuwing | 28-10-2021

3. Response Biomedical Corp., FSN-REC05102021, RAMP Troponin I

   RAMP® Troponin I Lot# M07797 will not provide test results as the lot card does not match the lot number on the cartridge barcode ...

   Waarschuwing | 28-10-2021

4. IMMUNOTECH SAS, FSN-FA-000664, Stem-Kit Reagents 50 Tests

   Beckman Coulter heeft ontdekt dat de aanbevolen bewaartemperatuur van het specimen en de stabiliteit van het bereide sample voor ...

   Waarschuwing | 28-10-2021

5. Siemens Healthcare Diagnostics IMC 21-05 - IMMULITE Systems AlaTOP Allergy Screen Assay

   Siemens Healthcare Diagnostics has confirmed through internal investigation that the IMMULITE®/IMMULITE® 1000 assay and IMMULITE® ...

   Waarschuwing | 12-10-2021

6. SSI Diagnostica A/S, Inc., Complaint no. 120-2021, ImmuView S. pneumoniae and L. pneumophila

   Due to a production error, the positive control is not correct.

   Waarschuwing | 08-10-2021

7. Beckman Coulter, Inc., FA-21046, Power Processor

   Naar aanleiding van interne onderzoeken hebben we ontdekt dat de spatbescherming die op de track aanwezig hoort te zijn, niet in ...

   Waarschuwing | 07-10-2021

8. Abbott Molecular, FA-AM-SEP2021-260, Alinity m SARS-CoV-2 AMP Kit ...

   This letter contains important information regarding potential false positive results when using Alinity m SARS-CoV-2 AMP Kit ...

   Waarschuwing | 02-09-2021

9. Roche Diagnostics, CN-588981 (SBN-RDS-Molecular Lab-2021-011), cobas EGFR Mutation Test v2

   Roche received complaints reporting the generation of false Mutation Detected results for the exon20 insertion (Ex20Ins) mutation ...

   Waarschuwing | 27-08-2021

10. Roche Diagnostics CN-603821 (SBN-RDS-POC-2021-010) - cobas SARS-CoV-2 & Influenza A/B Test

    Roche has received an increased number of complaints from customers when using cobas® SARS-CoV-2 & Influenza A/B Test for use on ...

    Waarschuwing | 30-07-2021