FDA Medical Device Recalls (openFDA)
BioCheck Inc: AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404 Quantitative determination of AFP concentration in human serum.
- Recall number
- Z-1626-2011
- Recalling firm
- BioCheck Inc
- Product
- AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404 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 of 25, 000 kits, all varieties
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog number: BC-1009; RN-34412 06-2010 RN-34387 06-2010 RN-34984 06-2010 RN-35612 10-2010 RN-36335 10-2010 RN-36637 01-2011 RN-37019 01-2011 RN-37374 03-2011 RN-38064 06-2011 RN-39414 09-2011 RN-39415 09-2011 RN-39948 12-2011 RN-40343 02-2012 Catalog number: BC-1010: RN-34226 05-2010 RN-34818 07-2010 RN-35158 09-2010 RN-35869 11-2010 RN-36129 12-2010 RN-37597 04-2011 RN-39545 10-2011 RN-39947 12-2011 RN-40304 02-2012 RN-40845 02-2012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOJ
- 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