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584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. SENTINEL CH. S.p.A., FSN-01/2021, ACE Control Set

    This letter contains important information regarding the ACE Control Set product REF 1667001.

    Waarschuwing | 30-04-2021

  2. bioMérieux SA, FSN-FSCA 5172, Sabouraud 2 agar (SAB2-T)

    During internal tes ting, a growth defect was observed for Candida on the product Sabouraud 2 agar tubes (SAB2 T).

    Waarschuwing | 28-04-2021

  3. 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

  4. Cepheid, FSN-21FAR005, Xpert BCR/ABL Ultra

    Cepheid heeft recentelijk geconstateerd dat er twee batches van Xpert® BCR-ABL Ultra foutieve resultaten rapporteren die in ...

    Waarschuwing | 07-04-2021

  5. Randox Laboratories Ltd, FSN-REC509, Randox Calibration Serum Level 3

    Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using ...

    Waarschuwing | 07-04-2021

  6. Siemens Healthcare Diagnostics Inc, FSN-CHI 21-01, ADVIA Chemistry System

    Siemens Healthcare Diagnostics has identified the following issues with the ADVIA Chemistry products.

    Waarschuwing | 01-04-2021

  7. Radiometer Medical ApS., FSN-FAN 915-416, ABL90 FLEX analyzer, ABL90 FLEX PLUS analyzer

    Radiometer has become aware of a potential issue with ABL90 FLEX and ABL90 FLEX PLUS analyzers.

    Waarschuwing | 31-03-2021

  8. 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

  9. Radiometer Medical ApS., FSN-FAN 915-415, PICO70

    Field Safety Notice: PICO70 Arterial Blood Sampler.

    Waarschuwing | 18-03-2021

  10. bioMerieux SA, FSN-FSCA 5109, VIDAS CMV IGM 30 TESTS

    URGENT FIELD SAFETY NOTICE VIDAS® CMV IgM; Calibration issue leading to potential delayed results.

    Waarschuwing | 18-03-2021

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