Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Illumina, QI-00398, VeriSeq™ NIPT Solution v2

    Illumina has received reports of samples in column 11 having low Non-Excluded Sites (NES) resulting in iFACT failures leading to ...

    Waarschuwing | 29-10-2021

  2. 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

  3. 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

  4. bioMérieux SA FSCA 5202-1 - VIDAS Anti-HBs Total II

    Based on complaints received with results identified as discordant and potential false positive by some customers, bioMérieux ...

    Waarschuwing | 29-07-2021

  5. Siemens Healthcare Diagnostics Inc., FSN-CC 21-06, ADVIA Centaur Syphilis

    The purpose of this communication is to inform you of an issue with the product ADVIA Centaur Syphilis.

    Waarschuwing | 17-05-2021

  6. Roche Diagnostics GmbH, FSN-CN-358714 (SBN-RDS-CPS-2021-003), IRON 2

    Urgent Field Safety Notice Iron Gen.2: throughput dependent signal drifts on cobas c 311, cobas c 501/502 and COBAS INTEGRA® 400 ...

    Waarschuwing | 13-04-2021

  7. Roche Molecular Systems, FSN-CN-560213,-563436,-566153(SBN-RMD-2021-005), cobas® SARS-CoV-2 & Influenza A/B Test

    Urgent Field Safety Notice cobas® SARS-CoV-2 & Influenza A/B – Invalids and False Positive results.

    Waarschuwing | 22-03-2021

  8. Microbiologics, Inc.,FSN-Recall 2020-003_0947, KWIK-STIK™ 0947P-K-LYFO-DISK_QC Sets&Panels 5193P

    Dringend bericht inzake de unassayed kwaliteitscontrolemateriaal voor microbiologische assays.

    Waarschuwing | 08-02-2021

  9. ABBOTT POINT OF CARE, FSN-APOC2020-007, i-STAT CG8+ and EG7+ Cartridges

    This letter contains important information regarding the i-STAT® CG8+ and EG7+ cartridges.

    Waarschuwing | 23-12-2020

  10. Siemens Healthcare Diagnostics ASW 21-02 - Atellica IM 1300_1600 and CH 930 Analyzer

    Siemens Healthcare Diagnostics has identified the following issues with the Atellica Solution products listed in Table 1, which ...

    Waarschuwing | 22-12-2020