Accurun 51 Multi-Marker Hepatitus Positive Control — recall 57209
Health Canada — Medical Devices · Canada · 2017-08-14 · Type II
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Reported risk: 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.
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