Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Siemens Healthcare Diagnostics Inc, ACHC 23-03, Atellica CH Toxicology Calibrator

    Siemens Healthcare Diagnostics Inc. received customer complaints regarding a positive bias for the Atellica CH Salicylate (Sal) ...

    Waarschuwing | 31-05-2023

  2. Phadia AB, QA2023-05, EliA GBM Well

    Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation ...

    Waarschuwing | 31-05-2023

  3. SENTINEL CH. S.p.A., 01.2023, CALiaGold Calibrator Control Set Sample Diluent

    Based on the data collected from some customer sites, a high recovery of CALiaGold Control Set IREFj 1151200 may be found.  

    Waarschuwing | 31-05-2023

  4. RAL Diagnostics, NC 23.042, Buffer solutions for automated systems

    De gebruiker heeft bacteriën gevonden in bloeduitstrijkjes en er werden intern klachten van klanten gemeld.

    Waarschuwing | 25-05-2023

  5. ROCAMED France,FSCA-03-2023-1,Urology suction tubing with pump body

    ROCAMED SAM has received complaints about Urology Suction Tubing with Pump Body of reference SOUR9200ST12 of lot R006497. The ...

    Waarschuwing | 22-05-2023

  6. MED TRUST Handelsges.m.b.H., FSN-2023-01, Wellion LUNA TEST STRIPS 10 GLU

    Re·call Wellion LUNA duo/trio meter sets and teststrips. During an unannounced audit by TUV Rheinland it was detected that the ...

    Waarschuwing | 04-05-2023

  7. Illumina Inc, QI-01093, NextSeq 550Dx Instrument . MiSeq Dx Instrument

    Illumina neemt contact met u op vanwege een cybersecurityprobleem in de software van de Universal Copy Service (UCS) dat is ...

    Waarschuwing | 28-04-2023

  8. Waters Corporation, 1218959-11.17.2021-003-C, Waters 3777C Sample Manager IVD

    After investigation, a defect has been found that can result in a single sample being injected and recorded against the incorrect ...

    Waarschuwing | 26-04-2023

  9. Beckman Coulter Inc., 23011, iQ200 Series DxU 850m and 840m Iris Analyzers

    Beckman Coulter heeft kennis genomen van een intermitterend probleem waarbij de optionele markering “Previous Sample Had Sperm” ...

    Waarschuwing | 20-04-2023

  10. Beckman Coulter Ireland Inc., 000884, Bicarbonate

    Beckman Coulter has confirmed a premature decrease in calibratior ODs for the following lots of Bicarbonate OSR6x90.

    Waarschuwing | 20-04-2023