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HIV combi PT (2014-08-27)
- Starting date:
- August 27, 2014
- 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-41351
Recalled products
- HIV combi PT
Reason
Potential deficiency in providing the correct Canadian package insert for specific lots of the HIV combi PT assay. The users were only provided the international version of the package insert. No false result could be generated since the difference between the two versions has no impact on test results or interpretation.
Affected products
A. HIV combi PT
Lot or serial number
- 17549402
- 17619002
- 17704401
- 17704402
- 17704403
Model or catalog number
- 05390095190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY