Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens Healthcare Diagnostics Limited ASI 19-04 Atellica CH 930 Analyzer
The purpose of this communication is to inform you of issues with the Atellica CH 930 Analyzer listed in Table 1 above, installed ...
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Roche Diagnostics GmbH IO-0000166 (SBN-CPS-2019-019) IGG-2 (Tina-quant IgG Gen.2)
As CSF samples have lower concentrations than serum samples, due to carry over, a CSF sample might yield discrepant higher ...
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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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Randox Laboratories, REC407, Rheumatoid Factor Standard, Liquid Protein Calibra
Randox is conducting a Device Modification for Rheumatoid Factor Standard and Liquid Protein Calibrator for the lots specified in ...
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Philips Electronics, CQ70126, LABOSYS
Philips heeft een fout geconstateerd bij de rapportage van antibiotica uitslagen voor de microbiologie.
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Roche Diagnostics GmbH CN-428741 (SBN-CPS-2019-014) ALB2 (Albumin Gen.2)BILT3 (Bilirubin Total Gen.3)
Roche has received a number of complaints about Albumin Gen.2 (ALB2) reagent lot 33962301 and Bilirubin Total Gen.3 (BILT3) ...
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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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Diamed, FSCA 005-19, Immunohaematology/blood bank analyser IVD, automat
An anomaly of the instrument has been observed when all the conditions described below are met:..
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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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Philips Electronics Nederland B.V. PBE-190801-001, LABOSYS
Philips heeft een fout geconstateerd in de electronische (HL7 2.4 ORU) rapportage van uitslagen voor LABOSYS indien deze volgens ...