Recall Z-1637-2011
BioCheck Inc · initiated December 22, 2010
Product
Toxoplasma IgG ELISA kit ; Toxoplasma IgM ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Codes / lots: Catalog number: BC-1085: RN-34273 01-2010 RN-34597 01-2010 RN-34786 07-2010 RN-34880 07-2010 RN-34958 08-2010 RN-35261 09-2010 RN-35443 09-2010 RN-35672 10-2010 RN-35987 11-2010 RN-36425 12-2010 RN-36685 01-2011 RN-36945 01-2011 RN-37256 01-2011 RN-37487 01-2011 RN-37853 05-2011 RN-37854 05-2011 RN-38035 06-2011 RN-38080 06-2011 RN-38245 07-2011 RN-38851 08-2011 RN-39496 10-2011 RN-39815 11-2011 RN-40183 11-2011 RN-40217 10-2011 RN-40214 11-2011 RN-40215 12-2011 RN-40215A 12-2011 RN-40216 01-2012 RN-40216A 01-2012 RN-39197 09-2011 RN-40769 04-2012 RN-40832 03-2012 RN-40860 04-2012 RN-41081 04-2012 RN-41204 04-2012 RN-41409 04-2012; Catalog number BC-1087: RN-34125 05-2010 RN-34126 05-2010 RN-34587 07-2010 RN-34644 07-2010 RN-34688 07-2010 RN-34712 07-2010 RN-34930 07-2010 RN-35069 08-2010 RN-35159 08-2010 RN-35245 09-2010 RN-35350 09-2010 RN-35405 09-2010 RN-35428 09-2010 RN-35516 09-2010 RN-35849 10-2010 RN-35850 10-2010 RN-35985 11-2010 RN-36222 12-2010 RN-36542 01-2011 RN-36543 01-2011 RN-36623 01-2011 RN-36624 01-2011 RN-36757 02-2011 RN-36998 02-2011 RN-37317 03-2011 RN-37318 03-2011 RN-37359 03-2011 RN-37611 04-2011 RN-37824 05-2011 RN-38043 05-2011 RN-38075 06-2011…
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-1637-2011
- Initiated
- December 22, 2010
- Posted by FDA
- March 11, 2011
- Terminated
- March 25, 2011
- Product code
- LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Quantity
- estiate 25,000 total kits, all varieties
- Distribution
- Nationwide distribution.
- Recalling firm
- BioCheck Inc, Foster City, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-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-1640-2011 | HSV-2 IgG ELISA kit ; HSV-2 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 |