Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-07, Atellica CH Lithium_2 (LITH_2); Atellica CH Lithium (Li)
Siemens Healthcare Diagnostics Inc. has confirmed customer complaints indicating the potential for falsely elevated LITH_2 and Li ...
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ZOLL Circulation, FSN-FSCA-2022-09-001, AutoPulse Platform (AP) Li-Ion Batteries
Sinds mei 2022 heeft het Post Market Surveillance Team (team voor toezicht na introductie op de markt) van ZOLL Circulation een ...
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Abbott Hematology, FA09SEP2022, Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module
The Alinity h-series System Control Center (SCC) Application Software Version 4.3 (and below) and the Local User Interface (LUI) ...
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Actim Oy, 725, Actim 1ngeni
It is possible that in some rare cases when the IGFBP-1 concentration in the sample is near the cut-off of the test, the Actim ...
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DiaMed GmbH, FSN-FSCA 002-22, IH-QC8
Following two customer complaints, it has been confirmed that tubes from the impacted lot may present clots of red blood cells ...
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Siemens Healthcare Diagnostics Products GmbH, PP-22-003-A-C, N Antiserum to Human IgG
Siemens Healthcare Diagnostics Products GmbH has confirmed that the N Antiserum to Human IgG lots listed in Tables 1 and 2 are ...
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Illumina, QI-00949, VeriSeq™ NIPT Solution v2
In September 2020, you received a new VeriSeq NIPT Solution v2 system installation which should have included WFM v2.4 on a ...
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Biomedical Data Solutions, 73555, Ortho Connect
When Cancelling an Edit during Result Review, Approved results are incorrectly saved using the cancelled data.
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Becton Dickinson GmbH, FSN-IDS-22-4528, Sabouraud Agar with Chloramphenicol, Sabouraud Agar with Gentamicin and Chloramphenicol, Sabouraud GC Agar / BBL™ CHROMagar™ Candida Medium
Based on customer feedback, BD has identified an outside supplier issue with this plate’s impregnated antibiotic, ...
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QIAGEN GmbH FSN_CI3026361- therascreen FGFR RGQ RT-PCR Kit
QIAGEN heeft een verhoogd voorvalpercentage vastgesteld van fout-positieve resultaten met de therascreen FGFR RGQ RT-PCR Kit ...