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Accurun 51 Multi-Marker Hepatitus Positive Control
- Starting date:
- July 3, 2017
- Posting date:
- August 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64136
Reason
Seracare is informing users that they have discovered that certain batches of Accurun 51 are positive for antibodies to HIV 1 and/or HIV 2, despite a claim on the package insert that the product is manufactured from serum or plasma that is negative for antibodies to HIV 1 and 2. There is no impact on the performance of the affected batches. In addition, the anti-HIV 1/2 positive stock used to manufacture the Accurun 51 products is treated with beta propiolactone and ultraviolet radiation to reduce the virus activity, minimizing any safety risk.
Affected products
Accurun 51 Multi-Marker Hepatitus Positive Control
Lot or serial number
- Batch 10164524
- Batch 10164525
- Batch 10231486
- Batch 10231487
Model or catalog number
- 2000-0040
- 2000-0041
- A51-5001
- A51-5005
Companies
- Manufacturer
-
Seracare Life Sciences, Inc.
37 Birch Street
Milford
01757
Massachusetts
UNITED STATES