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U.S. Department of Health and Human Services

Class 2 Device Recall CVM IgG ELISA kit

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  Class 2 Device Recall CVM 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-1638-2011
Recall Event ID 57506
Product Classification Multiplex flow immunoassay, t.Gondii, rubella and cmv. - Product Code OMI
Product CVM IgG ELISA kit ;
CVM IgM ELISA kit
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1089: RN-34043 02-2010 RN-34418 02-2010 RN-34795 07-2010  RN-34863 05-2010 RN-35253 08-2010 RN-35444 09-2010  RN-35908 11-2010 RN-36344 11-2010 RN-36366 12-2010  RN-36834 02-2011 RN-37257 03-2011 RN-37488 04-2011  RN-37910 05-2011 RN-38810 06-2011 RN-39366 06-2011  RN-39646 10-2011 RN-39646A 10-2011 RN-40690A 03-2012  RN-40690 03-2012 RN-40922 04-2012 RN-40114 12-2011 RN-40114A 12-2011 RN-40831 03-2012 RN-41340 04-201;  Catalog number BC-1091:  RN-33978 04-2010 RN-34259 05-2010 RN-34434 05-2010  RN-34588 04-2010 RN-34645 07-2010 RN-34649 07-2010  RN-35027 07-2010 RN-35028 07-2010 RN-35034 08-2010  RN-35140 07-2010 RN-35220 07-2010 RN-35308 09-2010  RN-35373 09-2010 RN-35621 09-2010 RN-35389 09-2010  RN-35520 09-2010 RN-35808 10-2010 RN-35965 11-2010  RN-35966 11-2010 RN-35967 11-2010 RN-35986 11-2010 RN-36113 12-2010 RN-36367 12-2010 RN-36481 01-2011  RN-36835 02-2011 RN-36893 02-2011 RN-37130 02-2011  RN-37319 03-2011 RN-37434 02-2011 RN-37556 03-2011  RN-37856 02-2011 RN-37912 03-2011 RN-37911 03-2011  RN-37913 03-2011 RN-37577 03-2011 RN-38076 03-2011  RN-38312 07-2011 RN-38836 05-2011 RN-38837 06-2011  RN-39036 08-2011 RN-39189 09-2011 RN-39550 10-2011 RN-39550A 10-2011 RN-39736 11-2011 RN-39843 11-2011  RN-39843A 11-2011 RN-39953 01-2012 RN-40187 01-2012  RN-40386 01-2012 RN-40725 01-2012 RN-40773 02-2013  RN-40943 02-2012 RN-40944 02-2012 RN-41319 02-2012  RN-41356 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 total kits,
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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