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U.S. Department of Health and Human Services

Class 2 Device Recall Visual hCG ELISA kit

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  Class 2 Device Recall Visual hCG 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-1634-2011
Recall Event ID 57506
Product Classification System, test, human chorionic gonadotropin - Product Code DHA
Product Visual hCG ELISA kit
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1045 RN-33907 01-2010 RN-34784 07-2010 RN-34789 07-2010  RN-35133 08-2010 RN-35143 07-2010 RN-35917 10-2010  RN-36411 10-2010 RN-37353 12-2010 RN-37354 04-2011  RN-37356 12-2010 RN-38063 04-2011 RN-39274 09-2011  RN-39674 09-2011 RN-40182 01-2012 RN-40521 03-2012  RN-41405 03-2012.    
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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