Recall Z-1627-2011 ยท DHX System, Test, Carcinoembryonic Antigen
BioCheck Inc
CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
| Date | Mar 11, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 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: info@biocheck.com |
| Quantity | estimate 25,000 kits, all varieties |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.