Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HSV1 IgG ELISA kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall HSV1 IgG 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-1639-2011
Recall Event ID 57506
Product Classification Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
Product HSV-1 IgG ELISA kit ;
HSV-1 IgM ELISA kit;
BioCheck, Foster City, CA 9440.

Quantitative determination of AFP concentration in human serum.
Code Information Catalog number: BC-1093: RN-33786 03-2010 RN-33956 03-2010 RN-34538 03-2010  RN-35037 08-2010 RN-35242 09-2010 RN-36114 12-2010  RN-37937 03-2011 RN-38809 07-2011 RN-38839 06-2011  RN-39279 09-2011 RN-40515 02-2012 RN-40515A 02-2012  N-40833 02-2012 RN-40835 02-2012 RN-41271 02-2012  RN-41301 02-2012 RN-41357 02-2012;  Catalog number BC-1095:  RN-33990 04-2010 RN-34548 02-2010 RN-34904 04-2010  RN-35427 09-2010 RN-35807 10-2010 RN-35889 10-2010  RN-37713 03-2011 RN-38218 04-2011 RN-38875 07-2011  RN-39471 10-2011 RN-40226 10-2011 RN-40226A 10-2011  RN-40516 03-2012 RN-40942 03-2012 RN-41214 03-2012.  
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 total 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.
-
-