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U.S. Department of Health and Human Services

Class 2 Device Recall HSV2 IgG ELISA kit

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  Class 2 Device Recall HSV2 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-1640-2011
Recall Event ID 57506
Product Classification Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
Product HSV-2 IgG ELISA kit ;
HSV-2 IgM ELISA kit;
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1097: RN-34184 02-2010 RN-34539 05-2010 RN-34865 05-2010  RN-35243 09-2010 RN-35671 10-2010 RN-36426 12-2010  RN-37081 02-2011 RN-38186 03-2011 RN-38841 07-2011  RN-39120 08-2011 RN-39367 09-2011 RN-39551 10-2011  RN-39551A 10-2011 RN-40115 12-2011 RN-40188 01-2012  RN-40188A 01-2012 RN-40407 02-2012 RN-40407A 02-2012  RN-40955 02-2012 RN-41080 04-2012 RN-41129 02-2012 RN-41131 02-2012 RN-41132 05-2012 RN-41413 02-2012;  Catalog number BC-1099:  RN-33991 02-2010 RN-34549 04-2010 RN-34714 03-2012 RN-34719 03-2012 RN-34876 07-2010 RN-35141 08-2010 RN-35453 07-2010 RN-35642 10-2010 RN-35650 10-2010 RN-35891 11-2010  RN-36061 12-2010 RN-36062 11-2010 RN-36345 12-2010  RN-36408 12-2010 RN-36686 01-2011 RN-37383 03-2011  RN-37457 12-2010 RN-37535 12-2010 RN-37536 01-2011  RN-37537 03-2011 RN-37607 03-2011 RN-37817 03-2011  RN-37985 05-2011 RN-37986 05-2011 RN-38289 06-2011  RN-39196 05-2011 RN-39610 10-2011 RN-40520 10-2011 RN-40520A 10-2011 RN-40734 11-2011 RN-41084 04-2012  RN-41198 03-2012 RN-41285 01-2012 RN-41315 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 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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