Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Abbott Diagnostics FA16MAY2019 - ARCHITECT Assays
The purpose of this letter is to inform you of an update to the REAGENTS and SPECIMEN COLLECTION AND HANDLING/ PREPARATION FOR ...
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Arkray Afc-fsca-2019-001 - AUTION HYBRID AU-4050
Regarding the Fully Automated Integrated Urine Analyzer AUTION HYBRID AU4050, it was found that incorrect patient information is ...
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Beckman Coulter FA-000046 - Access Immunoassay Systems
Beckman Coulter heeft de mogelijke interferentie-effecten van biotine (maximaal 1200 ng/ml) op alle biotine-gemedieerde ...
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Abbott Laboratories, FA01MAY2019, ARCHITECT c4000 / c8000 / c16000 Mixer
There is the potential for the mixer blade, attached to the mixer with a screw and nut, to separate from the mixer.
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Bio-Rad_DiaMed GmbH FSCA 002-19 - IH-QC1
Recently we have been made aware that the anti-D (RH1) less than 0.05 ID/ml contained in the IH-QC1 has given weaker reactions ...
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Axis-Shield 077565 - Alere NT-proBNP Control_Alere NT-proBNP Calibrator
All of the lots listed above demonstrate a time dependent, stability drift in results returned from NT-proBNP testing on both the ...
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Linkage Biosciences, MW 19-001, SureTyper Software
When a session is opened in SureTyper v 6.0.0 for the first time, the software is not detecting the instrument that the raw data ...
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Thermo Fisher PO5133A.2635614 - Oxoid Bacillus Cereus Medium (MYP)
An investigation has confirmed that Bacillus Cereus Medium (MYP), PO5133A, lot 2635614 has been incorrectly labelled. The outer ...
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Ortho Clinical Diagnostics CL2019-090 - VITROS Chemistry Products CK Slides
Ortho Clinical Diagnostics determined that VITROS CK Slides do not meet the current on-analyzer stability time of < 1 week when ...
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Quidel FCA-001-19 - Triage TOX Drug Screen Control 1
Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed ...