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U.S. Department of Health and Human Services

Class 2 Device Recall AFP ELISA Kit

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  Class 2 Device Recall AFP ELISA Kit see related information
Date Initiated by Firm December 22, 2010
Date Posted March 11, 2011
Recall Status1 Terminated 3 on March 25, 2011
Recall Number Z-1626-2011
Recall Event ID 57506
Product Classification Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
Product AFP ELISA Kit;
AFP ELISA kit (Extended range);
BioCheck, Foster City, CA 94404

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1009; RN-34412 06-2010  RN-34387 06-2010 RN-34984 06-2010 RN-35612 10-2010  RN-36335 10-2010 RN-36637 01-2011 RN-37019 01-2011 RN-37374 03-2011 RN-38064 06-2011 RN-39414 09-2011  RN-39415 09-2011 RN-39948 12-2011 RN-40343 02-2012  Catalog number: BC-1010: RN-34226 05-2010  RN-34818 07-2010 RN-35158 09-2010 RN-35869 11-2010  RN-36129 12-2010 RN-37597 04-2011 RN-39545 10-2011  RN-39947 12-2011 RN-40304 02-2012 RN-40845 02-2012. 
Recalling Firm/
Manufacturer		 BioCheck Inc
323 Vintage Park Dr
Foster City CA 94404-1186
For Additional Information Contact Anna Pao
650-573-1968
Manufacturer Reason
for Recall		 Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
FDA Determined
Cause 2		 PMA
Action The firm, BioCheck, sent an "URGENT: DEVICE RECALL" letter dated December 22, 2010 to all customers. The letter described the product, problem and actions to be taken by customers. The customer were instructed to examine their inventory for the affected lots, if found, discontinue distributing the lots and promptly return via Fedex to BioCheck at 323 Vintage Park Drive, Foster City, CA 94404, Attn: RETURNED GOODS; immediately contact their accounts, if they further distributed the product, and inform them of the Recall, and complete and return the response form via email at: info@biocheck.com or fax to (650-573-1969) immediately. If you have any questions, please call (650) -573-1968 anytime during office hours (8:30am to 5:30pm Pacific time).
Quantity in Commerce estimate of 25, 000 kits, all varieties
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
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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