Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Biohit Oyj, 144-22, BIOHIT ColonView quick test

   lf the specified kit lot has been used, a minor possibility for a false negative result still exists. In such a case there would ...

   Waarschuwing | 30-12-2022

2. Leica Biosystems Melbourne Pty Ltd, 202209-01, ThermoBrite Elite

   Thermische uitschakeling Er is vastgesteld dat de thermische uitschakelingsschakelaar, een automatisch resettende thermische ...

   Waarschuwing | 19-12-2022

3. Leica Biosystems Newcastle, IR 66/22, NovocastraTM Muscle Specific Actin

   Leica Biosystems Newcastle recently became aware the IFU of affected device mentioned above incorrectly states a suggested ...

   Waarschuwing | 15-12-2022

4. Randox Laboratories Ltd., REC629, Randox Specific Protein Control Levels 1-3

   Rheumatoid Factor (RF) is a protein whose levels are increased in patients with Rheumatoid Arthritis. Delay in reporting results ...

   Waarschuwing | 10-12-2022

5. Abbott Molecular, FA-AM-NOV2022-283, Alinity m Resp-4-Plex AMP Kit

   Abbott has received reports of an increase in reactive negative controls and false positive results, with certain lots of Alinity ...

   Waarschuwing | 09-12-2022

6. Siemens Medical Solutions Diagnostics, AIMC 23-01, Atellica IM Free Prostate-Specific Antigen fPSA

   The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...

   Waarschuwing | 07-12-2022

7. Abbott Molecular, Inc., FSN-FA-AM-OCT2022-282, Alinity m System

   This letter contains important information regarding your Alinity m System; Specifically, the current software installed on your ...

   Waarschuwing | 15-11-2022

8. DiaMed GmbH, FSN-FSCA 003-22, IH-500

   We would like to share with you, and your team, information about an issue that could be observed when performing ABO grouping ...

   Waarschuwing | 10-11-2022

9. The Binding Site Group Limited, FSN-AE061, Freelite® Human Lambda Free Kit for use on the Siemens BN ProSpec®

   Na een aantal meldingen van klanten en interne tests hebben we vastgesteld dat de kit vermeld in tabel 1 de optische limiet van ...

   Waarschuwing | 03-11-2022

10. Oxoid Deutschland GmbH, FSN-, Columbia CAP Agar with Sheep Blood

    A technical investigation has concluded that Proteus spp grew and swarmed on the plate.  

    Waarschuwing | 13-10-2022