Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Abbott FA24MAR2016 - CELL-DYN Emerald Cleaner
Abbott has identified occurrences where the CELL-DYN Emerald analyzer generates Quality Control (QC) Out Of Range Low for ...
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AB Germa FSCA_ENG 160317 - vacuum pump foot pump
We have identified a quality deviation in the latest production lot of Footrest Vacuum Pumps. During Germa quality check before ...
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Leica FSCA-2016-01 - 3200MD series and 4500MD series
An issue has been identified with Analyst MD software where under certain conditions a user can be presented with incorrect ...
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Siemens CC 16-07 - ACS 180,ADVIA Centaur Calibrator E
Siemens Healthcare Diagnostics has confirmed a lot to lot bias with Calibrator E for the ADVIA Centaur Testosterone assay.
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Radiometer Medical ApS FAN 915-347 - Troponin T (8-test) Test Kit, bnp, d-dimer, TnI
RADIOMETER has recently become aware of a potential risk of receiving false negative results with the AQT90 FLEX Test Kit Boxes ...
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Sekisui Diagnostics ACET-506-2016-01-22 - Sekure Acetaminophen L3K Assay
Sekisui has investigated complaints related to the formation of crystals in the R2 reagent and/or shift of controls when left ...
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bioMérieux FSCA 2752 - API® ZYM Bx2
Based on discrepant results (False negative results) reported from the field, bioMérieux initiated a complaint investigation to ...
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Siemens Healthcare Diagnostics Products GmbH PH-16-003 - BCS System, BCS XP Analyzer System, OVIO032, OVOB032
Siemens Healthcare Diagnostics has observed that in very rare cases false short clotting times for PT on BCS and BCS XP with Dade ...
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Medis Medical Image Systems B.V.16M0003 - QIvus 2.0, 2.1, 2.2. en 3.0
"The IMap™, V , TVC Chemogram™ and OCT modules of Qlvus are lntended for research use only and are not to be used for clinical ...
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Becton Dickinson BDB-15-657 - FMC7 FITC
The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%. The adverse ...