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Health product recall

COBAS TAQSCREEN WEST NILE VIRUS TEST (2015-06-15)

Starting date:
June 15, 2015
Posting date:
July 8, 2015
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-54102

Recalled Product

A.COBAS TAQSCREEN WEST NILE VIRUS TEST

Reason

It was discovered that version 4 of the package insert for the cobas TaqScreen West Nile Virus Test references the system configuration C when it should be referencing the system configuration D.

Affected products

A.COBAS TAQSCREEN WEST NILE VIRUS TEST

Lot or serial number

All Lots

Model or catalog number

04741722190

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

UNITED STATES