Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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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Biokit SV 19_01 - QUANTIA RF
Biokit has confirmed calibration failures with the indicated product and lot. Upon trying to calibrate the lot 01518H000, the ...
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Abbott, FA29MAR2019, Alinity hq Analyzer
There is a potential for delay in the generation of patient results due to the increase in step loss on axis errors and seizing ...
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Siemens Healthcare Diagnostics Inc.-CHI 19-01 - ADVIA Chemistry HVN Mech Automation Kit- Aptio0464323imension Vista® Lactate Dehydrogenase (LDI)t Lab System
Our records indicate that your facility may have an ADVIA Chemistry XPT connected to Aptio by Siemens, Aptio by Inpeco or FlexLab ...
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Institut Virion\Serion GmbH CN20190122 - Immunomat SW v2.06.3
lf the reagent check function is deactivated, the lmmunomat may, provided vials of different conjugate strengths are ...
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Siemens PI-17-007 - Enzygnost
Siemens Healthcare Diagnostics has confirmed that the above listed lots of Enzygnost® HBsAg 6.0 show an increased number of ...
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Radiometer, ABL800, FAN 915-374
It has come to our attention that in certain situations, the registration receipt received after placing a sampler in the FLEXQ ...
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Hyphen BioMed, BIOPHEN ARIXTRA® CONTROL PLASMA
We inform you that we have identified on the flyer, an error on the acceptance range of the C1 control.
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Field Safety Notice: Radiometer Medical ApS, AUTOCHECK 5+ level 2 ampoules
Radiometer has recently become aware of AUTOCHECK 5+ level 2 ampoules, may give incorrect results for pO2.
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Field Safety Notice: Beckman Coulter - AQUIOS CL Flow Cytometry System
As a result of internal investigations, BEC has learned that an erroneous configuration setting during servicing may be possible ...