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U.S. Department of Health and Human Services

Class 2 Device Recall Rubella IgG ELISA kit

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  Class 2 Device Recall Rubella 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-1636-2011
Recall Event ID 57506
Product Classification Enzyme linked immunoabsorbent assay, rubella - Product Code LFX
Product Rubella IgG ELISA kit ;
Rubella IgM ELISA kit
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1081: RN-33954 03-2010 RN-34103 03-2010 RN-34432 03-2010  RN-34509 03-2010 RN-34874 06-2010 RN-34928 07-2010  RN-35088 08-2010 RN-35199 08-2010 RN-35487 09-2010  RN-35805 10-2010 RN-36037 11-2010 RN-36211 12-2010  RN-36478 12-2010 RN-36783 02-2011 RN-36946 02-2011  RN-37223 03-2011 RN-37225 02-2011 RN-37612 03-2011  RN-37825 02-2011 RN-37974 03-2011 RN-38321 03-2011 RN-38811 07-2011 RN-38832 05-2011 RN-38833 06-2011  RN-38834 07-2011 RN-39034 08-2011 RN-39277 09-2011  RN-39497 10-2011 RN-39577 07-2011 RN-39721 11-2011  RN-39930 12-2011 RN-39930A 12-2011 RN-40185 12-2011  RN-40185A 12-2011 RN-40364 02-2012 RN-40364A 02-2012  RN-40412 01-2012 RN-40771 02-2012  RN-40972 02-2012 RN-41318 02-2012.  BC-1083: RN-34104 02-2010 RN-34433 05-2010 RN-34510 06-2010  RN-34929 07-2010 RN-35035 08-2010 RN-35198 08-2010  RN-35307 09-2010 RN-35388 09-2010 RN-35314 09-2010  RN-35517 09-2010 RN-35519 09-2010 RN-35806 10-2010  RN-35903 11-2010 RN-36066 11-2010 RN-36112 12-2010  RN-36363 12-2010 RN-36479 12-2010 RN-36480 12-2010  RN-36916 12-2010 RN-36947 02-2011 RN-36760 02-2011 RN-37080 02-2011 RN-37129 12-2010 RN-37224 02-2011  RN-37613 02-2011 RN-37435 12-2010 RN-37800 02-2011  RN-37895 05-2011 RN-37975 02-2011 RN-38286 06-2011  RN-38287 06-2011 RN-38322 07-2011 RN-38358 04-2011  RN-38852 08-2011 RN-38812 07-2011 RN-39035 08-2011  RN-39212 08-2011 RN-39278 09-2011 RN-39498 10-2011  RN-39720 11-2011 RN-39720A 11-2011 RN-39765 11-2011 RN-39952 12-2011 RN-40186 12-2011 RN-40186A 12-2011  RN-40227 10-2011 RN-40227A 10-2011 RN-40228 09-2011  RN-40228A 09-2011 RN-40365 01-2012 RN-40365A 01-2012 RN-41288 01-2012 RN-41289 01-2012  RN-41290 01-2012 RN-41412 01-2012.    
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 total, 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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