FDA Medical Device Recalls (openFDA)
BioCheck Inc: CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
- Recall number
- Z-1630-2011
- Recalling firm
- BioCheck Inc
- Product
- CA19-9 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
- not on file
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Catalog number: BC-1017; RN-34237 05-2010 RN-33400 02-2010 RN-34586 05-2010 RN-34850 05-2010 RN-35131 08-2010 RN-35474 09-2010 RN-35854 09-2010 RN-36593 01-2011 RN-37142 03-2011 RN-37903 04-2011 RN-39461 09-2011 RN-40394 02-2012 RN-40916 04-2012.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NIG
- 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