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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63609
Product Type Biologics
Status Ongoing
Recalling Firm Bio-Rad Laboratories
City Redmond
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern Product was distributed nationwide and to Australia and France.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Multispot HIV-1/HIV-2 Rapid Test has a catalog # 25228. Expiration date:April 23, 2013 Class III Bio-Rad Multispot HIV-1/HIV-2 Rapid Test, with reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membrances when using some vials of Conjugate, were distributed. 1 Unit B-0354-13