Date Initiated by Firm |
February 07, 2003 |
Date Posted |
March 06, 2003 |
Recall Status1 |
Terminated 3 on May 02, 2003 |
Recall Number |
Z-0616-03 |
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. CHLINT, Lot No. 133354, 133174. Foreign distribution. |
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 |
56 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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