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U.S. Department of Health and Human Services

Class 2 Device Recall AntiHBC EIA

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  Class 2 Device Recall AntiHBC EIA see related information
Date Initiated by Firm January 07, 2008
Date Posted August 20, 2008
Recall Status1 Terminated 3 on March 07, 2011
Recall Number Z-1189-2008
Recall Event ID 46728
PMA Number P060031 
Product Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
Code Information Lot Number 232BGG
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact
425-498-1709
Manufacturer Reason
for Recall		 Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.
FDA Determined
Cause 2		 Process control
Action Bio-Rad called each customer and alerted them to the issue on 1/7-8/2008. A letter was faxed and sent via overnight carrier (DHL) to each customer site on 1/8/2008. Customers were told not to use the affected lot of the product and to discard it. The firm will provide another lot of the product to customers.
Quantity in Commerce 31 distributed
Distribution Nationwide Distribution.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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