Z-1640-2011

HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative determination of AFP...

Name: Z-1640-2011 HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative determination of AFP...
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 HSV-2 IgG ELISA kit ; HSV-2 IgM 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-1640-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-03-11
Terminated: 2011-03-25
Recalling firm: BioCheck Inc
Product: HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Product code: LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
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 total kits, all varieties.
Distribution: Nationwide distribution.
Product codes and lots: Catalog number: BC-1097: RN-34184 02-2010 RN-34539 05-2010 RN-34865 05-2010 RN-35243 09-2010 RN-35671 10-2010 RN-36426 12-2010 RN-37081 02-2011 RN-38186 03-2011 RN-38841 07-2011 RN-39120 08-2011 RN-39367 09-2011 RN-39551 10-2011 RN-39551A 10-2011 RN-40115 12-2011 RN-40188 01-2012 RN-40188A 01-2012 RN-40407 02-2012 RN-40407A 02-2012 RN-40955 02-2012 RN-41080 04-2012 RN-41129 02-2012 RN-41131 02-2012 RN-41132 05-2012 RN-41413 02-2012; Catalog number BC-1099: RN-33991 02-2010 RN-34549 04-2010 RN-34714 03-2012 RN-34719 03-2012 RN-34876 07-2010 RN-35141 08-2010 RN-35453 07-2010 RN-35642 10-2010 RN-35650 10-2010 RN-35891 11-2010 RN-36061 12-2010 RN-36062 11-2010 RN-36345 12-2010 RN-36408 12-2010 RN-36686 01-2011 RN-37383 03-2011 RN-37457 12-2010 RN-37535 12-2010 RN-37536 01-2011 RN-37537 03-2011 RN-37607 03-2011 RN-37817 03-2011 RN-37985 05-2011 RN-37986 05-2011 RN-38289 06-2011 RN-39196 05-2011 RN-39610 10-2011 RN-40520 10-2011 RN-40520A 10-2011 RN-40734 11-2011 RN-41084 04-2012 RN-41198 03-2012 RN-41285 01-2012 RN-41315 01-2012.

Product code LGC

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)