FDA Medical Device Recalls (openFDA)
BioCheck Inc: CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
- Recall number
- Z-1628-2011
- Recalling firm
- BioCheck Inc
- Product
- CA125 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-1013; RN-34041 04-2010 RN-34413 06-2010 RN-34847 06-2012 RN-35053 08-2010 RN-35341 08-2010 RN-35494 09-2010 RN-36176 12-2010 RN-36220 12-2010 RN-36733 02-2011 RN-37061 03-2011 RN-37755 05-2011 RN-38062 06-2011 RN-38866 08-2011 RN-39311 09-2011 RN-39691 11-2011 RN-39946 11-2011 RN-40220 01-2012 RN-40467 02-2012 RN-41008 04-2012 RN-41424 04-2012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LTK
- 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