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U.S. Department of Health and Human Services

Class 2 Device Recall CEA ELISA Kit

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  Class 2 Device Recall CEA ELISA Kit see related information
Date Initiated by Firm December 22, 2010
Date Posted March 11, 2011
Recall Status1 Terminated 3 on March 25, 2011
Recall Number Z-1627-2011
Recall Event ID 57506
Product Classification System, test, carcinoembryonic antigen - Product Code DHX
Product CEA ELISA Kit.
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1011;  RN-33968 04-2010 RN-34421 06-2010 RN-34473 06-2010  RN-34853 07-2010 RN-35157 08-2010 RN-35486 08-2010  RN-35815 09-2010 RN-36179 12-2010 RN-36221 12-2010  RN-36751 02-2011 RN-37124 02-2011 RN-37125 02-2011  RN-37892 05-2011 RN-37953 02-2011 RN-38320 07-2011  RN-38307 07-2011 RN-39144 08-2011 RN-39416 10-2011  RN-39417 10-2011 RN-40110 12-2011 RN-40464 12-2011  RN-40982 04-2012 RN-41177 04-2012.    
Recalling Firm/
Manufacturer		 BioCheck Inc
323 Vintage Park Dr
Foster City CA 94404-1186
For Additional Information Contact Anna Pao
650-573-1968
Manufacturer 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 2		 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 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).
Quantity in Commerce estimate 25,000 kits, all varieties
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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