Date Initiated by Firm |
March 15, 2005 |
Date Posted |
June 21, 2005 |
Recall Status1 |
Terminated 3 on February 10, 2006 |
Recall Number |
Z-0913-05 |
Recall Event ID |
31719 |
510(K)Number |
K964721
|
Product Classification |
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine - Product Code KLI
|
Product |
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK. |
Code Information |
Lot 710, Exp. 7/28/05 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
|
For Additional Information Contact |
Judy M. Strzepek 908-218-8524
|
Manufacturer Reason for Recall |
Potential for positively biased results in QC and patient samples.
|
FDA Determined Cause 2 |
Other |
Action |
Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack. |
Quantity in Commerce |
Domestic - 1359; International - 840 |
Distribution |
Nationwide distribution. Product shipped worldwide via J&J foreign affiliates. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = KLI and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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