FDA Medical Device Recalls (openFDA)
BioCheck Inc: Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
- Recall number
- Z-1634-2011
- Recalling firm
- BioCheck Inc
- Product
- Visual hCG 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 kits, all varieties.
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog number: BC-1045 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DHA
- 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