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U.S. Department of Health and Human Services

Class 2 Device Recall Rapid IVD test kit for Chlamydia antigen..

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  Class 2 Device Recall Rapid IVD test kit for Chlamydia antigen.. see related information
Date Initiated by Firm February 07, 2003
Date Posted March 06, 2003
Recall Status1 Terminated 3 on May 02, 2003
Recall Number Z-0615-03
Recall Event ID 25589
510(K)Number K951010  
Product Classification Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) - Product Code LJC
Product Chlamydia OIA. For in vitro diagnostic use,
Code Information Catalog No. CHL30, Lot No. 132117, 132117A,133101  
Recalling Firm/
Manufacturer		 Thermo Biostar, Incorporated
331 South 104th Street
Louisville CO 80027
Manufacturer Reason
for Recall		 Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
FDA Determined
Cause 2		 Other
Action All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.
Quantity in Commerce 286 units
Distribution Nationwide, and to France, New Zealand and Spain.
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.
510(K) Database 510(K)s with Product Code = LJC and Original Applicant = BIOSTAR, INC.
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