Health product recall

Elecsys Anti-HAV (2018-06-19)

Starting date:
June 19, 2018
Posting date:
July 19, 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-67256

Affected products

Elecsys Anti-HAV

Reason

The measuring range of the Elecsys Anti-HCV (CAT #04854977190 and #07026757190) will need to be reduced for the upper end values for the cobas e411, cobas e601-602 and cobas e801 module until further notice.

Affected products

Elecsys Anti-HAV

Lot or serial number

28324101
30319501

Model or catalog number

04854977190
07026757190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY