Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. SENTINEL CH. S.p.A, FSN-07/2020, Zine

   This letter contains important information regarding the ZINC product REF 17640H lot 90227.

   Waarschuwing | 30-10-2020

2. Beckman Coulter, 24033, Access HBc Ab

   Beckman Coulter heeft vastgesteld dat het Access HBc Ab reagenskit lotnummer dat in de bovenstaande tabel wordt vermeld, mogelijk ...

   Waarschuwing | 25-06-2024

3. Becton, Dickinson and Company, IDS-23-4851, BD Sensi-Disc

   Becton Dickinson heeft door middel van een recente evaluatie van het DB BBLTM Sensi-DiscTM-product bevestigd dat achtentwintig ...

   Waarschuwing | 22-01-2024

4. Abbott Diagnostics Scarborough, Inc., 2023 09, ID NOW Instrument

   Sommige klanten hebben een toename van het aantal vals-positieve testresultaten voor influenza B gemeld bij gebruik van het ...

   Waarschuwing | 17-01-2024

5. Leica Biosystems Nussloch GmbH, CN-237848, Leica Biosystems Tissue processor

   As part of our post market surveillance, we have been made aware of an issue regarding poorly processed and/or damaged biopsy ...

   Waarschuwing | 11-12-2023

6. LDN Labor Diagnostika Nord GmbH & Co. KG, DE/0000040010, Androstanediol-Glucuronide ELISA

   For the product AA E-1500 Androstanediol Glucuronides ELISA Lot 230083( it has been detected that the standards D (AA E-1504 Lot ...

   Waarschuwing | 08-12-2023

7. BioFire Diagnosticss, LLC, FSCA 5761-1, BIOFIRE FILMARRAY TORCH

   When turning on BIOFIRE TORCH systems, arcing inside of the power switch may result in carbon build-up on the switch contacts. ...

   Waarschuwing | 10-11-2023

8. Randox Laboratories Ltd., Liquid Assayed Chemistry Control Premium Plus Leve

   Randox Laboratories can confirm that there has been a transcription error in the lnstructions for Use (IFU) for the Liquid ...

   Waarschuwing | 15-09-2023

9. Alba Bioscience Limited (Ltd.), 00003-2023, ALBAcyte® Reagent Red Cells A1

   Investigations have identified that the product is mis-labeled in that one of the three units used to manufacture this reagent ...

   Waarschuwing | 31-08-2023

10. AB SCIEX Pte. Ltd., FSCA-2023-177083, 4500MD and Citrine LC-MS/MS Systems

    In rare occasions, the combination of a leak of a highly flammable solvent at the ion source pro be, and an electrical discharge ...

    Waarschuwing | 21-08-2023