Health product recall

Kit COBAS 6800/8800 HCV 96T CE-IVD (2018-11-19)

Starting date:
November 19, 2018
Posting date:
December 10, 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-68556

Affected products

Kit COBAS 6800/8800 HCV 96T CE-IVD

Reason

There is a potential that the cobas HCV of lot number Y28363 can be labeled incorrectly. The content on the label affixed to the carton and to the COBAS HCV test cassettes is correct and appropriate for lot Y28363 of the COBAS HCV test. However, the carton displays markings of the cobas HEV nucleic acid tests for use on the cobas 6800/8800 systems

Affected products

Kit COBAS 6800/8800 HCV 96T CE-IVD

Lot or serial number

Y28363

Model or catalog number

06997732190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY