Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Chromsystems FSC 1-2020 - Multilevel Plasma Calibrator Set Neuroleptics 1
lnternal investigations demonstrate that existing lot #2219 on the market of 3PLUS l Multilevel Plasma Calibrator Set ...
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Axis-Shield Diagnostics FSCA079658 - Alere NT-proBNP
The purpose of this letter is to inform you of a product recall for the Alere NT-proBNP Calibrator and Control lot numbers listed ...
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Greiner Bio-One R002_20 - MiniCollect 9NC Coagulation Tube
As a result of our post market clinical follow up process and based on internal testing, it was identified that MiniCollect® 9NC ...
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Siemens ACHC20-07 - Atellica CH Ethyl Alcohol (ETOH) assay
Siemens Healthcare Diagnostics Inc. investigation has confirmed that the Atellica CH ETOH assay may exhibit a positive bias in QC ...
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Siemens Healthcare Diagnostics Inc ASW20-03 Atellica CH 930 Analyzer
Editing an assay Test Definition and switching to another assay’s Test Definition screen without saving the changes using the ...
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Siemens PH-20-006 - Dade Ci-Trol 1
Siemens Healthcare Diagnostics has observed that assigned confidence intervals for Fibrinogen are broader than expected. This ...
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Siemens ACHC 20-02 - Dimension Total Bilirubin (TBI) assay
Siemens Healthcare Diagnostics has become aware that the United Kingdom Medicines and Healthcare products Regulatory Agency ...
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Siemens IMC20-01 - IMMULITE 1000_2000 (XPi) Estradiol
The purpose of this communication is to inform you of high discordant Estradiol results for some patient samples with the ...
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bioMérieux FSCA 4647 - VIDAS NT-proBNP2
Following customers’ complaints about error analysis during calibration, bioMérieux investigation has confirmed an issue with the ...
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Stago RIS-19-0037 - STA Compact, STA Compact Max, STA-R Evolution, STA-R Max
Diagnostica Stago has detected there is a risk of sample to sample carry-over of this molecule on Stago instruments, and, has ...