Recall Z-1628-2011
BioCheck Inc · initiated December 22, 2010
Product
CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Codes / lots: Catalog number: BC-1013; RN-34041 04-2010 RN-34413 06-2010 RN-34847 06-2012 RN-35053 08-2010 RN-35341 08-2010 RN-35494 09-2010 RN-36176 12-2010 RN-36220 12-2010 RN-36733 02-2011 RN-37061 03-2011 RN-37755 05-2011 RN-38062 06-2011 RN-38866 08-2011 RN-39311 09-2011 RN-39691 11-2011 RN-39946 11-2011 RN-40220 01-2012 RN-40467 02-2012 RN-41008 04-2012 RN-41424 04-2012.
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-1628-2011
- Initiated
- December 22, 2010
- Posted by FDA
- March 11, 2011
- Terminated
- March 25, 2011
- Product code
- LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- Quantity
- estimate 25, 000 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-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-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 |