Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. Abbott Diagnostics FA20JUL2020 - Alinity hq Analyzer

   This Product Correction letter is to inform you of a potential issue with the Alinity hq Analyzer which may impact the ...

   Waarschuwing | 20-07-2020

4. Roche Diagnostics CN-494220 - Elecsys PTH (1-84)

   The issue observed is a calibration signal for calibrator level 2 varying between two signal levels: ~25’000 cts vs ~35’000 cts. ...

   Waarschuwing | 17-07-2020

5. MarDx Diagnostic, R009-20, Uni-Gold S pneumoniae

   Ontoereikendheid in de gebruiksaanwijzing van het product, - gedeelte over beoogd gebruik.

   Waarschuwing | 29-06-2020

6. Roche Diagnostics CN-481196 - Elecsys Troponin T hs - update 5, June 2020

   As described in the version 1 and 2 of the FSN-CPS-2019-022, the lots 419260, 436777 of Elecsys Troponin T hs (08569873 190) and ...

   Waarschuwing | 29-06-2020

7. 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

8. 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

9. Beckman Coulter FA-000402 - DxA 5000

   De gebruiksinstructies voor de DxA 5000 zijn mogelijk verwarrend omtrent het hergebruik van monster-ID's. Beckman Coulter heeft ...

   Waarschuwing | 23-06-2020

10. Siemens Healthcare Diagnostics Inc, FSN-ACHC 20-10, Chemistry Calibrator

    The purpose of this communication is to inform you of an issue with the Chemistry Calibrator (Chem Cal) lots indicated and ...

    Waarschuwing | 22-06-2020