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Class 2 Device Recall H pylori IgG ELISA kit

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Class 2 Device Recall H pylori IgG ELISA kit

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Date Initiated by Firm	December 22, 2010
Date Posted	March 11, 2011
Recall Status¹	Terminated ³ on March 25, 2011
Recall Number	Z-1635-2011
Recall Event ID	57506
Product Classification	Campylobacter pylori - Product Code LYR
Product	H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Code Information	Catalog number: BC-1051: 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 RN-39118 06-2011 RN-39460 10-2011 RN-39814 11-2011 RN-39909 08-2011 RN-39910 09-2011 RN-39911 07-2011 RN-40112 12-2011 RN-40361 02-2012 RN-40363 02-2012 RN-41005 04-2012 RN-41217 04-2012 RN-41229 04-2012 RN-41287 05-2012; Catalog number: BC-1052: RN-34225 01-2010 RN-34419 06-2010 RN-34700 07-2010 RN-35092 08-2010 RN-35674 10-2010 RN-36038 11-2010 RN-36115 11-2010 RN-36829 11-2010 RN-37222 11-2010 RN-37390 11-2010 RN-37737 02-2011 RN-37738 03-2011 RN-37739 03-2011 RN-38061 06-2011 RN-38156 07-2011 RN-39119 09-2011 RN-39145 08-2011 RN-39813 11-2011 RN-40113 12-2011 RN-40733 12-2011 RN-41004 12-2011 RN-41205 04-2012 RN-41206 04-2012 RN-41215 05-2012 RN-41216 04-2012; Catalog number BC-1053: RN-34105 04-2010 RN-34110 02-2010 RN-34511 05-2010 RN-34931 07-2010 RN-35033 05-2010 RN-35090 08-2010 RN-35204 08-2010 RN-35454 09-2010 RN-35455 09-2010 RN-35890 10-2010 RN-36627 01-2011 RN-36997 02-2011 RN-37691 03-2011 RN-38253 03-2011 RN-38323 03-2011 RN-38870 07-2011 RN-38874 07-2011 RN-39280 09-2011 RN-39611 10-2011 RN-40408 01-2012 RN-41057 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 25, 000 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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