Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Randox Laboratories Ltd., FSN-REC679, LIQUID URINE CONTROL LEVEL 2

   Randox Laboratories is conducting a Device Recall for Liquid Urine Controls Level 2, UC5074, lot 1209UC due to the following:  ...

   Waarschuwing | 24-07-2023

10. HYPHEN BioMed, FSN-FSCA29, BIOPHEN TM Protein C LRT

    The R2 of the products listed above contains Cesium Chlodride. Following information from our supplier, this substance has ...

    Waarschuwing | 16-03-2023