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

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  Reason
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  Affected products

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