Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
Roche Diagnostics GmbH CN-116536 (GC-0791409) and CN-253267 - cobas b123 <3> POC system, cobas b123 <4> POC syst bilirubine
We have become aware of an issue that may lead to erroneously low results for neonatal bilirubin on cobas b 123 systems in rare ...
-
Siemens DC16-03 - Vista Enzyme 2 calibrator and Dimension Enz II cal 529
Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is ...
-
MDSS 1627497-2016-00001-R; MDSS ref.: IVD16.035 - Histoplasma Yeast CF Antigen Dilute
As part of post-market surveillance activities, the above device was found to have bacterial contamination. We are aware of one ...
-
Leica FSCA-2016-01 - 3200MD series and 4500MD series
An issue has been identified with Analyst MD software where under certain conditions a user can be presented with incorrect ...
-
Siemens CC 16-07 - ACS 180,ADVIA Centaur Calibrator E
Siemens Healthcare Diagnostics has confirmed a lot to lot bias with Calibrator E for the ADVIA Centaur Testosterone assay.
-
Sekisui Diagnostics ACET-506-2016-01-22 - Sekure Acetaminophen L3K Assay
Sekisui has investigated complaints related to the formation of crystals in the R2 reagent and/or shift of controls when left ...
-
bioMérieux FSCA 2752 - API® ZYM Bx2
Based on discrepant results (False negative results) reported from the field, bioMérieux initiated a complaint investigation to ...
-
Beckman Coulter FSCA-26321, EU-120115-009 - MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels
Beckman Coulter has confirmed falsely negative results for Voges- Proskauer (VP) (pale-pink/brown/colorless) with Quality Control ...
-
IJS Global ATJ_FCA-0001 - Pima Analyser
As part of our post-market surveillance activities we have identified an increase in reports of mechanica failure and prolonged ...
-
bioMérieux SA FCA 3204 - Etest® MBL MP/MPI 8/2 B30
The bioMérieux UK subsidiary reported to the International Distribution Centre (IDC) that they had observed a non-conformity on ...