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Terminated

CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

FDA Recall Z-1627-2011 · Posted 2011-03-11

Recalling FirmBioCheck Inc
Recall StatusTerminated
Product CodeDHX
Date Initiated2010-12-22
Date Terminated2011-03-25
Product Quantityestimate 25,000 kits, all varieties

Reason for Recall

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

Firm 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: [email protected] 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).

Root Cause

PMA

Distribution Pattern

Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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