Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
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Abbott, FA24MAY2019, ARCHITECT BNP Calibrator
Use of impacted calibrator lots may result in falsely elevated patient results. Use of impacted control lots may result in ...
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Roche Diagnostics, IO-0000163, Elecsys Syphilis (200 test/kit),
Erroneous Values used for Interference of IgM and IgG
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bioMerieux Inc, FSCA 4360, Chocolat PolyViteX (PVX)
We hebben klachten ontvangen van klanten over een afwijkende groei (beperkt of afwezig) voor de volgende stammen:...
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Randox Laboratories, REC398, HUMAN ASSAYED MULTI-SERA Level 2
Randox has identified a labelling error in the value sheet for Human Assayed Controls Level 2 lots 1306UN, 1308UN and 1309UN.
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Roche Diagnostics, CN-451459, AssayTip/AssayCup
We wish to advise that we have identified defective assay cups from lots 19817113 and 19818113
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Roche Diagnostics, CN-431825, IGA-2 (Tina-quant IgA Gen.2)
Internal investigations of the affected c packs revealed contamination of R1 with R3 (containing antibody).
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Siemens, ACHC 19-02, Atellica and ADVIA Creatine Kinase (CK_L) Reagent
The purpose of this communication is to inform you of an issue with the products listed in Table 1 above and provide instructions ...
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Abbott Diagnostics FA21MAY2019 - Alinity ci-series System Control Module
Abbott has identified an issue with all on-market versions of Alinity ci-series software where the software may not detect an ...
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Luminex Molecualr Diagnostics, Inc - RC-18-012 - xTAG® Gastrointestinal Pathogen Panel (GPP)
We have received customer complaints regarding xTAG® Gastrointestinal Pathogen Panel (GPP) reporting lower MS2 MFI values. ...
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Abbott, FA16MAY2019A, Alinity c
The purpose of this letter is to inform you of an update to the REAGENTS and SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS ...