Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
bioMerieux Inc, FSN-FSCA 4864, Chocolat PolyViteX (PVX)
bioMerieux Benelux meldt dringend bericht over productverbetering CHOCOLATE POLYVITEX (Ref. 43109 -43101).
-
Gentian AS CC-167 - Gentian Cystatin C Calibrator and Calibrator Kit
The identified lots of calibrators have shown to measure incorrect high values over time compared to the assigned values when ...
-
Ventana Medical Systems Inc, FSN-CN-469460 /CN-479223 (SB-RTD-2020-001), BENCHMARK ULTRA STAINER MODULE
Complaints were filed reporting fluid leaks within BenchMark ULTRA instruments that created an electrical short inside the power ...
-
Dako_Agilent CAPA00852 - Autostainer Link 48_Plus_Classic
Er is een redelijke kans dat er een kleurafwijking optreedt als gevolg van lekkage van Autostainer. Dit kan op zijn beurt leiden ...
-
Abbott FA28AUG2020 - ARCHITECT Galectin‐3 Reagent
The purpose of this letter is to inform you of a product recall for ARCHITECT Galectin‐3 Reagent lot 10037M800. We have ...
-
Siemens Healthcare Diagnostics Inc., FSN-AIMC 20-05, ADVIA Centaur HER-2/neu (H2n)
The purpose of this communication is to inform you of an issue with ADVIA Centaur HER-2/neu (H2n) Assay, ADVIA Centaur HER-2/neu ...
-
Siemens VC 20-02 - Dimension Vista® ALPI Flex® reagent cartridge
Siemens Healthcare Diagnostics Inc. has observed a rare occurrence of low outlier results generated with Alkaline Phosphatase ...
-
Ortho Clinical Diagnostics Inc, FSN-CL2020-206, ORTHO VISION and VISION Max Analyzers
This notification is regarding the potential for intermittent false positive results being generated on ORTHO VISION® or ORTHO ...
-
Inpeco SA FSCA-AP2-202008-03 - Aptio Automation
The firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) has the potential to mis-associate sample IDs leading to ...
-
Siemens POC 20-011 - Atellica 800_Atellica 1500
Siemens Healthcare Diagnostics has confirmed that falsely depressed results may occur on Atellica UAS 800 systems using software ...