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