Z-1631-2011

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

Name: Z-1631-2011 PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum
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 PSA 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-1631-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-03-11
Terminated: 2011-03-25
Recalling firm: BioCheck Inc
Product: PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Product code: LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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-1019; RN-34301 05-2010 RN-34353 05-2010 RN-34657 07-2010 RN-34877 07-2010 RN-35018 08-2010 RN-35057 08-2010 RN-35485 09-2010 RN-35699 10-2010 RN-35975 11-2010 RN-35976 11-2010 RN-36412 12-2010 RN-36523 12-2010 RN-36606 01-2011 RN-36821 02-2011 RN-37060 02-2011 RN-37370 03-2011 RN-37371 03-2011 RN-37603 02-2011 RN-37639 04-2011 RN-37645 04-2011 RN-37774 05-2011 RN-38040 06-2011 RN-38155 06-2011 RN-38178 07-2011 RN-38247 07-2011 RN-38913 08-2011 RN-39190 08-2011 RN-39219 08-2011 RN-39250 09-2011 RN-39529 10-2011 RN-39703 11-2011 RN-39833 11-2011 RN-39960 12-2011 RN-39963 12-2011 RN-40108 12-2011 RN-40109 12-2011 RN-40261 12-2011 RN-40340 02-2012 RN-40435 02-2012 RN-40585 03-2012 RN-40586 03-2012 RN-40791 03-2012 RN-40909 03-2012 RN-40915 03-2012 RN-41193 05-2012 RN-41293 05-2012

Product code LTJ

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)