Z-1626-2011

AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404 Quantitative determination of...

Name: Z-1626-2011 AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404 Quantitative determination of...
Creator: BioCheck Inc
Published: 2010-12-22
License: https://open.fda.gov/license/

BioCheck Inc / initiated 2010-12-22 / Terminated / root cause: labeling and UDI

FDA source

BioCheck Inc began a recall of AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404 Quantitative determination of AFP concentration in human serum on 2010-12-22. The reason FDA records is "Product labels indicate that the products are for IVD use and they do not have an approved 510(k)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1626-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-03-11
Terminated: 2011-03-25
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.
Product code: LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Reason for recall: Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Root cause tag: labeling and UDI
FDA 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: [email protected] 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 in commerce: estimate of 25, 000 kits, all varieties
Distribution: Nationwide distribution.
Product codes and lots: 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.

Product code LOJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)