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Health product recall

Vitek MS (2013-10-07)

Starting date:
October 7, 2013
Posting date:
November 25, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36859

Recalled products

A. Vitek MS 

Reason

Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old transient recorder (TR) board (Ref. 6200350). Extenisve testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk repeated results for different spots.

Affected products

A. Vitek MS 

Lot or serial number

Serial numbers below 50039 and above 60000 are affected (exception 50050 is also affected).

Model or catalog number
  • 410710
  • 410895
Companies
Manufacturer
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE