Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
Ortho Clinical Diagnostics (Ortho), LLC, FSN-CL2021-080, ORTHO VISION and ORTHO VISION Max Analyzers
The purpose of this notification is to inform you that the Wrong Liquid Level (WLL) check will not occur in specific ...
-
UmanDiagnostics AB,FSN-273AV, NF-light ELISA
Urgent Field Safety Notice In-vitro diagnostic immunoassay device intended for quantitative determinations of human Neurofilament ...
-
bioMerieux SA, FSN-FSCA 5087, VIDAS CMV IGM 30 TESTS-30205
DRINGEND BERICHT OVER PRODUCTVERBETERING VIDAS® CMV IgM - Kalibratieprobleem met mogelijk vertraagde resultaten tot gevolg–loten ...
-
DiaMed GmbH, FSN-FSCA 001-21, DiaClon Anti-N and DiaClon Anti-M/N
Bio-Rad is voluntarily conducting a Field Safety Corrective Action for the DiaClon Anti-N and DiaClon Anti-M/N.
-
Roche Diagnostics GmbH, FSN-IO-0000170 (SBN-RDS-CPS-2021-001), Anti-Xa
During internal verification studies, an interference by streptokinase was detected for the assay Anti-Xa on cobas t 511/t 711.
-
Illumina, Inc. FSN-NCR-82352 - VeriSeq NIPT Solution v2 - update February 2021
Het gebruik van donkere, niet-doorschijnende platen met 96 diepe wells bemoeilijkt de visuele inspectie van de platen met ...
-
Microbiologics, Inc.,FSN-Recall 2020-003_0947, KWIK-STIK™ 0947P-K-LYFO-DISK_QC Sets&Panels 5193P
Dringend bericht inzake de unassayed kwaliteitscontrolemateriaal voor microbiologische assays.
-
BioFire Diagnostics, LLC, FSN-FSCA 5046, BCID and BCID2 Panel
Dringend bericht over product correctie BioFire FilmArray® - BioFire BCID Panel And BioFire BCID2 Panel.
-
Siemens Healthcare Diagnostics Inc., FSN-AIMC 21-02, Atellica IM and ADVIA Centaur fPSA Calibrator
Siemens Healthcare Diagnostics Inc. has confirmed the potential for invalid calibrations due to calibrator ratios resulting high ...
-
Phadia AB,FSN-QA2020-08, EliA dsDNA Well
The purpose of this letter is to advise you that Phadia AB, part of Thermo Fisher Scientific, is issuing a Field Safety ...