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COBAS AmpliScreen HIV-1 TEST V1.5 (2015-05-04)
- Starting date:
- May 4, 2015
- Posting date:
- June 1, 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-53575
Recalled Products
- COBAS AmpliScreen HIV-1 TEST V1.5
Reason
The recall is related to a wrong version of the method sheet version 3.0 that was distributed by mistake in the COBAS AmpliScreen HIV-1 test of lot number t10217.
Affected products
A. COBAS AmpliScreen HIV-1 TEST V1.5
Lot or serial number
T10217
Model or catalog number
03322114018
Companies
- Manufacturer
-
Roche Molecular Systems Inc.
1080 US Highway 202
Branchurg
08876
UNITED STATES