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U.S. Department of Health and Human Services

Class 2 Device Recall PSA ELISA Kit

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  Class 2 Device Recall PSA 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-1631-2011
Recall Event ID 57506
Product Classification Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
Product PSA ELISA Kit.
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1019;  RN-34301 05-2010 RN-34353 05-2010 RN-34657 07-2010  RN-34877 07-2010 RN-35018 08-2010 RN-35057 08-2010  RN-35485 09-2010 RN-35699 10-2010 RN-35975 11-2010  RN-35976 11-2010 RN-36412 12-2010 RN-36523 12-2010  RN-36606 01-2011 RN-36821 02-2011 RN-37060 02-2011  RN-37370 03-2011 RN-37371 03-2011 RN-37603 02-2011  RN-37639 04-2011 RN-37645 04-2011 RN-37774 05-2011 RN-38040 06-2011 RN-38155 06-2011 RN-38178 07-2011  RN-38247 07-2011 RN-38913 08-2011 RN-39190 08-2011  RN-39219 08-2011 RN-39250 09-2011 RN-39529 10-2011  RN-39703 11-2011 RN-39833 11-2011 RN-39960 12-2011  RN-39963 12-2011 RN-40108 12-2011 RN-40109 12-2011  RN-40261 12-2011 RN-40340 02-2012 RN-40435 02-2012  RN-40585 03-2012 RN-40586 03-2012 RN-40791 03-2012 RN-40909 03-2012 RN-40915 03-2012 RN-41193 05-2012  RN-41293 05-2012  
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 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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