Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens Healthcare Diagnostics Inc. POC 19-021 Atellica UAS 800 Analyzer
Siemens Healthcare Diagnostics has confirmed that a communication error could be generated on the system application software ...
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BIOMERIEUX SA FSCA 4459 VIDAS FT4
VIDAS® FT4 is an automated quantitative enzyme immunoassay for use with the instruments of the VIDAS® family, to determine free ...
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Roche Diagnostics GmbH IO-0000165 SFTR (Tina-quant Soluble Transferrin Receptor)
During the feasibility study for the new Tina-quant Soluble Transferrin Receptor assay generation, it was observed that the ...
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Biomatrica, 2019-001, LBgard Blood Collection Tube
A review of all data reports referenced in the Technical File for LBgard, along with data from additional studies performed after ...
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Roche Diagnostics, CN-467273, AssayTip/AssayCup tray
Roche has identified AssayTips with abnormal internal structure in some lots.
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Tem Innovations, 600000957, r ex-tem
We have received customer complaints on Lot No. 42255701 of ROTEM r ex-tem, reporting prolonged clotting times (CT) with multiple ...
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Ortho Clinical Diagnostics CL2019-202 - ORTHO VISION (Max) Analyzer
Ortho has been made aware that in some instances, when an analyzer returns to the operational state when exiting IDLE mode, a ...
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Bio-Rad_DiaMed GmbH FSCA 004-19 - DiaClon Rh-Subgroups + K
Further to customer's reports, we have been able to confirm that interference can be observed in the anti-e microtube with QC ...
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Abbott Diagnostics FA10JUN2019 - Alinity ci-series System Control Module
Abbott has identified an issue with all on‐market versions of Alinity ci‐series Software where reuse of reaction vessels (RVs) ...
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bioMérieux SA, FSCA 4379, VIDAS® NT-proBNP2
The investigation confirmed that the calibration of lot 1007078560 cannot be perfomed on VIDAS® PC instrument.