FDA Medical Device Recalls (openFDA)
BioCheck Inc: HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
- Recall number
- Z-1639-2011
- Recalling firm
- BioCheck Inc
- Product
- HSV-1 IgG ELISA kit ; HSV-1 IgM 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 kits, all varieties.
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog number: BC-1093: RN-33786 03-2010 RN-33956 03-2010 RN-34538 03-2010 RN-35037 08-2010 RN-35242 09-2010 RN-36114 12-2010 RN-37937 03-2011 RN-38809 07-2011 RN-38839 06-2011 RN-39279 09-2011 RN-40515 02-2012 RN-40515A 02-2012 N-40833 02-2012 RN-40835 02-2012 RN-41271 02-2012 RN-41301 02-2012 RN-41357 02-2012; Catalog number BC-1095: RN-33990 04-2010 RN-34548 02-2010 RN-34904 04-2010 RN-35427 09-2010 RN-35807 10-2010 RN-35889 10-2010 RN-37713 03-2011 RN-38218 04-2011 RN-38875 07-2011 RN-39471 10-2011 RN-40226 10-2011 RN-40226A 10-2011 RN-40516 03-2012 RN-40942 03-2012 RN-41214 03-2012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGC
- 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