Health product recall

Cobas AmpliPrep/Cobas TaqMan HCV Quantitative & Qualitative Test, V2.0 (2019-10-23)

Starting date:
October 23, 2019
Posting date:
December 6, 2019
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-71796

Last updated: 2019-12-06

Affected Products

A. Cobas AmpliPrep/Cobas TaqMan HCV Quantitative Test, V2.0
B. Cobas AmpliPrep/Cobas TaqMan HCV Qualitative Test, V2.0

Reason

Potential of over-quantified false positive results with the Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) HCV Test, V2.0 CE- IVD caused by abnormal curve shape. This situation is corrected with the updated test definition file (TDF) versions for the Cobas AmpliPrep/Cobas TaqMan HCV Test, V2.

Affected products

A. Cobas AmpliPrep/Cobas TaqMan HCV Quantitative Test, V2.0

Lot or serial number

E13535
E15765
E24584
E29153
F01038
F06109

Model or catalog number

5532264190

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

New Jersey

UNITED STATES

B. Cobas AmpliPrep/Cobas TaqMan HCV Qualitative Test, V2.0

Lot or serial number

E14233
E21368
E32787

Model or catalog number

5480477190

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

New Jersey

UNITED STATES