Health product recall

Elecsys DHEA-S (2018-01-05)

Starting date:
January 5, 2018
Posting date:
January 29, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-65836

Affected products

Elecsys DHEA-S

Reason

The method sheet of Elecsys DHEA-S for Cobas E411, Cobas E601, Cobas E602 and modular analytics E systems has been updated for several changes and the revised method sheet now contains the following information: no interference was observed from rheumatoid factors up to a concentration of 80 IU/ml.

Affected products

Elecsys DHEA-S

Lot or serial number
  • 22745001
  • 22745002
Model or catalog number

03000087122

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY