Z-1628-2011

CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human...

Name: Z-1628-2011 CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human...
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 CA125 ELISA Kit. BioCheck, Foster City, CA 9440. 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-1628-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-03-11
Terminated: 2011-03-25
Recalling firm: BioCheck Inc
Product: CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Product code: LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
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 25, 000 kits, all varieties.
Distribution: Nationwide distribution.
Product codes and lots: 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.

Product code LTK

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)