FDA Medical Device Recalls (openFDA)
BioCheck Inc: 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.
- Recall number
- Z-1635-2011
- Recalling firm
- BioCheck Inc
- 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.
- Status
- Terminated
- Initiated
- 2010-12-22
- Posted
- 2011-03-11
- Terminated
- 2011-03-25
- Reason
- Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- Root cause
- 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
- estimate 25, 000 total, all varieties
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYR
- Firm FEI
- 3002564473
- Firm city
- Foster City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28