Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Hitachi High Technologies Corporation (HHT), FSN-CN-509982,CN-530429 (SBN-CPS- 2020-013), cobas 8000 Core Unit,cobas pro sample supply unit,cobas c 513 analyzer commercial system

   Roche has received one customer complaint for the cobas 8000 modular analyzer series where due to a software limitation the ...

   Waarschuwing | 30-11-2020

2. Roche Molecular Systems, FSN-CN-516475, cobas z 480 analyzer

   Roche received complaint cases alleging false positive or invalid results with select cobas® 4800 IVD assays.

   Waarschuwing | 24-11-2020

3. Siemens Healthcare Diagnostics Inc, FSN-ACHC 20-18, ADVIA and Atellica Fructosamine reagent

   The purpose of this communication is to inform you of a positive bias with Quality Control (QC) and patient samples when using ...

   Waarschuwing | 15-10-2020

4. Siemens Healthcare Diagnostics Inc, Inc, FSN-VC 20-03, Dimension Vista High Sensitivity Troponin I Flex

   High Sensitivity Troponin I (TNIH) Flex® reagent cartridge Negative Bias with Patient Samples.

   Waarschuwing | 01-10-2020

5. Roche Molecular Systems, FSN-CN-494142 (SB-RMD-2020-001), MagNA Pure 96 System

   As a result of a customer complaint, it was discovered that, only when using the Sample Transfer protocol version 3.0 on the ...

   Waarschuwing | 05-06-2020

6. Fast-Track Diagnostics S.a.r.l., FSN-FA-2020-04, FTD Stool parasites

   Update van de gebruiksaanwijzing voor de FTD Stool parasites-kit.

   Waarschuwing | 08-05-2020

7. Fast-Track Diagnostics S.a.r.l. FA-2020-02 FTD Vesicular rash

   Het doel van deze communicatie is u te informeren over prestatieproblemen in verband met de ontoereikendheid van validatie en ...

   Waarschuwing | 10-04-2020

8. Siemens IMC20-01 - IMMULITE 1000_2000 (XPi) Estradiol

   The purpose of this communication is to inform you of high discordant Estradiol results for some patient samples with the ...

   Waarschuwing | 24-02-2020

9. Siemens Healthcare Diagnostics Limited ASI 19-04 Atellica CH 930 Analyzer

   The purpose of this communication is to inform you of issues with the Atellica CH 930 Analyzer listed in Table 1 above, installed ...

   Waarschuwing | 04-09-2019

10. Roche Diagnostics GmbH CN-428741 (SBN-CPS-2019-014) ALB2 (Albumin Gen.2)BILT3 (Bilirubin Total Gen.3)

    Roche has received a number of complaints about Albumin Gen.2 (ALB2) reagent lot 33962301 and Bilirubin Total Gen.3 (BILT3) ...

    Waarschuwing | 28-08-2019