Recall Z-1640-2011

BioCheck Inc · initiated December 22, 2010

Terminated

Product

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

Codes / 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.

Reason for recall

Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

FDA-determined cause: PMA

Action taken

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).

Details

Recall number
Z-1640-2011
Initiated
December 22, 2010
Posted by FDA
March 11, 2011
Terminated
March 25, 2011
Product code
LGC – Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Quantity
estimate 25,000 total kits, all varieties.
Distribution
Nationwide distribution.
Recalling firm
BioCheck Inc, Foster City, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1626-2011 AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA 94404…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1627-2011 CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1628-2011 CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1629-2011 CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1630-2011 CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1631-2011 PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1632-2011 Free PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1633-2011 Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1634-2011 Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1635-2011 H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1636-2011 Rubella IgG ELISA kit ; Rubella IgM ELISA kit BioCheck, Foster City, CA 9440.…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1637-2011 Toxoplasma IgG ELISA kit ; Toxoplasma IgM ELISA kit BioCheck, Foster City, CA 9440.…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1638-2011 CVM IgG ELISA kit ; CVM IgM ELISA kit BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1639-2011 HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1641-2011 CK-MB ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated
Z-1642-2011 Myeloperoxidase (MPO) ELISA kit ; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). 12/22/2010Terminated