Recall Z-1638-2011
BioCheck Inc · initiated December 22, 2010
Product
CVM IgG ELISA kit ; CVM IgM ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Codes / lots: Catalog number: BC-1089: RN-34043 02-2010 RN-34418 02-2010 RN-34795 07-2010 RN-34863 05-2010 RN-35253 08-2010 RN-35444 09-2010 RN-35908 11-2010 RN-36344 11-2010 RN-36366 12-2010 RN-36834 02-2011 RN-37257 03-2011 RN-37488 04-2011 RN-37910 05-2011 RN-38810 06-2011 RN-39366 06-2011 RN-39646 10-2011 RN-39646A 10-2011 RN-40690A 03-2012 RN-40690 03-2012 RN-40922 04-2012 RN-40114 12-2011 RN-40114A 12-2011 RN-40831 03-2012 RN-41340 04-201; Catalog number BC-1091: RN-33978 04-2010 RN-34259 05-2010 RN-34434 05-2010 RN-34588 04-2010 RN-34645 07-2010 RN-34649 07-2010 RN-35027 07-2010 RN-35028 07-2010 RN-35034 08-2010 RN-35140 07-2010 RN-35220 07-2010 RN-35308 09-2010 RN-35373 09-2010 RN-35621 09-2010 RN-35389 09-2010 RN-35520 09-2010 RN-35808 10-2010 RN-35965 11-2010 RN-35966 11-2010 RN-35967 11-2010 RN-35986 11-2010 RN-36113 12-2010 RN-36367 12-2010 RN-36481 01-2011 RN-36835 02-2011 RN-36893 02-2011 RN-37130 02-2011 RN-37319 03-2011 RN-37434 02-2011 RN-37556 03-2011 RN-37856 02-2011 RN-37912 03-2011 RN-37911 03-2011 RN-37913 03-2011 RN-37577 03-2011 RN-38076 03-2011 RN-38312 07-2011 RN-38836 05-2011 RN-38837 06-2011 RN-39036 08-2011 RN-39189 09-2011 RN-39550 10-2011 RN-39550A 10-2011…
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-1638-2011
- Initiated
- December 22, 2010
- Posted by FDA
- March 11, 2011
- Terminated
- March 25, 2011
- Product code
- OMI – Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- Quantity
- estimate of 25, 000 total kits,
- 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-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-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 |