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U.S. Department of Health and Human Services

Class 2 Device Recall Toxoplasma IgG ELISA kit

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  Class 2 Device Recall Toxoplasma IgG 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-1637-2011
Recall Event ID 57506
Product Classification Enzyme linked immunoabsorbent assay, toxoplasma gondii - Product Code LGD
Product Toxoplasma IgG ELISA kit ;
Toxoplasma IgM ELISA kit
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1085: RN-34273 01-2010 RN-34597 01-2010 RN-34786 07-2010  RN-34880 07-2010 RN-34958 08-2010 RN-35261 09-2010  RN-35443 09-2010 RN-35672 10-2010 RN-35987 11-2010  RN-36425 12-2010 RN-36685 01-2011 RN-36945 01-2011  RN-37256 01-2011 RN-37487 01-2011 RN-37853 05-2011  RN-37854 05-2011 RN-38035 06-2011 RN-38080 06-2011  RN-38245 07-2011 RN-38851 08-2011 RN-39496 10-2011 RN-39815 11-2011 RN-40183 11-2011 RN-40217 10-2011  RN-40214 11-2011 RN-40215 12-2011 RN-40215A 12-2011  RN-40216 01-2012 RN-40216A 01-2012 RN-39197 09-2011  RN-40769 04-2012 RN-40832 03-2012 RN-40860 04-2012  RN-41081 04-2012 RN-41204 04-2012 RN-41409 04-2012;  Catalog number BC-1087: RN-34125 05-2010 RN-34126 05-2010 RN-34587 07-2010  RN-34644 07-2010 RN-34688 07-2010 RN-34712 07-2010  RN-34930 07-2010 RN-35069 08-2010 RN-35159 08-2010  RN-35245 09-2010 RN-35350 09-2010 RN-35405 09-2010  RN-35428 09-2010 RN-35516 09-2010 RN-35849 10-2010  RN-35850 10-2010 RN-35985 11-2010 RN-36222 12-2010  RN-36542 01-2011 RN-36543 01-2011 RN-36623 01-2011 RN-36624 01-2011 RN-36757 02-2011 RN-36998 02-2011  RN-37317 03-2011 RN-37318 03-2011 RN-37359 03-2011  RN-37611 04-2011 RN-37824 05-2011 RN-38043 05-2011  RN-38075 06-2011 RN-38288 07-2011 RN-38876 08-2011  RN-39055 08-2011 RN-39333 08-2011 RN-39334 08-2011  RN-39458 10-2011 RN-39459 10-2011 RN-39645 10-2011  RN-39684 10-2011 RN-39685 10-2011 RN-39824 11-2011 RN-39824A 11-2011 RN-39825 11-2011 RN-40184 12-2011  RN-40184A 12-2011 RN-40473 02-2012 RN-40473A 02-2012  RN-40770 03-2012 RN-40861 03-2012 RN-41056 03-2012  RN-41317 03-2012 RN-41410 03-2012 RN-41411 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 estiate 25,000 total 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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