Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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 ...

   Waarschuwing | 26-08-2020

2. Roche IO-0000167 (SB-CPS-2020-007) - Elecsys Anti-TPO assay

   The internal documentation of the Elecsys Anti-TPO assay on cobas e 411, cobas e 601 and cobas e 602 platforms was checked as ...

   Waarschuwing | 31-07-2020

3. DiaSorin S.p.A FN-200731 - LIAISON® Measles lgM

   DiaSorin S.p.a. internal testing confirmed, for the lot in object, a reduction of index value of samples. Such decrease could ...

   Waarschuwing | 31-07-2020

4. Randox Laboratories Ltd, FSN-REC471, RANDOX LIPASE (LPS)

   Randox have confirmed imprecision of quality control and patient samples when using Randox Lipase reagent batches listed in the ...

   Waarschuwing | 26-06-2020

5. Siemens Healthcare Diagnostics Inc, FSN-CC 20-06, ADVIA Centaur® XP Rubella G (Rub G) en ADVIA Centaur® XP Rubella M (Rub M)

   The purpose of this communication is to inform you that Siemens Healthcare Diagnostics Inc. has confirmed customer complaints ...

   Waarschuwing | 23-06-2020

6. Radiometer Medical ApS, FSN-FAN 915-412, ABL800 with FlexQ

   Radiometer has become aware that there is a potential risk of patient mix-up on ABL800 analyzers with FLEXQ sampler tray.

   Waarschuwing | 06-05-2020

7. Phadia AB, FSN-QA2020-02, EliA Stool Extraction Kit (see section 8)

   The purpose of this letter is to advise you that Phadia AB, part of Thermo Fisher Scientific, is issuing a Field Safety ...

   Waarschuwing | 01-05-2020

8. Becton Dickinson and Company, FSN-IDS-20-1985, BD BBL™ Gram Crystal Violet 250mL & Grain Stain Ki

   BD is issuing this Field Safety Notice to remove one specific lot of BD BBL™ Gram Crystal Violet 250mL and one specific lot of BD ...

   Waarschuwing | 28-04-2020

9. Radiometer Medical ApS FAN 915-411 ABL80 FLEX CO-OX

   Radiometer has become aware that the internal barcode reader, included in all versions of the ABL80 analyzer, may potentially ...

   Waarschuwing | 23-04-2020

10. Life Technologies Corporation, a part of Thermo Fisher Scientific PR423912 Gibco® Gurr Buffer Tablets

    We have become aware through customer complaints that two (2) lots of Gibco® Gurr Buffer Tablets (Catalog #: 10582-013, lot ...

    Waarschuwing | 21-04-2020