Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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DNA Genotek, 200018182, ORAcollect DNA / ORAcollect RNA / ORAcollect Dx
As a result, in a small subset of products, the amount of available stabilizing liquid may be lower than expected.
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Radiometer FAN 915-420 - PICO50 Arterial Blood Sampler
Radiometer has become aware of an issue with PICO50 Arterial Blood Sampler. The issue relates to the sterile barrier system for ...
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Helena Biosciences NC476 - SAS Free Kappa_Lambda IEF Kit
Further to customer feedback regarding the performance of the SAS Free Kappa IEF Kit: REF 102208 and SAS Free Lambda IEF Kit: REF ...
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Abbott GmbH FA24MAR2022 - Alinity i Homocysteine Reagent Kit
Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control ...
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Abbott Molecular, Inc., FSN-FA-AM-SEP2021-260 & FA-AM-SEP2021-260v2, Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kit
This is a follow-up to Urgent Field Safety Notice FA-AM-SEP2021-260 regarding potential false positive results when using Alinity ...
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Illumina, QI-000509, NextSeq 550Dx
Illumina heeft een probleem vastgesteld dat kortsluiting kan veroorzaken in de behuizing van het instrument.
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Siemens Healthcare Diagnostics AIMC 22-03 - Atellica® Solution and ADVIA Centaur® Systems
Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens ...
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Siemens Healthcare Diagnostics POC 22-002 - Atellica® UAS 800 Urine Sediment Analyzer & Atellica® 1500 Automated Urinalysis System
Siemens Healthcare Diagnostics has confirmed that the door gas spring which holds the analyzer door open is failing before its ...
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Abbott Molecular FA-AM-MAR2022-269 - Alinity m HBV AMP Kit
Abbott has received reports of falsely elevated results when using the Alinity m HBV AMP Kit. Data analysis has determined that ...
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SENTINEL FSCA 01/2022 - CALiaGOLD Control Set
An accuracy issue using Sentinel CALiaGold® Control Set REF 1151200 has been encountered, when testing the control material, ...