FDA Medical Device Recalls (openFDA)
BioCheck Inc: CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
- Recall number
- Z-1627-2011
- Recalling firm
- BioCheck Inc
- Product
- CEA 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-1011; RN-33968 04-2010 RN-34421 06-2010 RN-34473 06-2010 RN-34853 07-2010 RN-35157 08-2010 RN-35486 08-2010 RN-35815 09-2010 RN-36179 12-2010 RN-36221 12-2010 RN-36751 02-2011 RN-37124 02-2011 RN-37125 02-2011 RN-37892 05-2011 RN-37953 02-2011 RN-38320 07-2011 RN-38307 07-2011 RN-39144 08-2011 RN-39416 10-2011 RN-39417 10-2011 RN-40110 12-2011 RN-40464 12-2011 RN-40982 04-2012 RN-41177 04-2012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DHX
- 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