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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
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/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Judy M. Strzepek
Manufacturer Reason
for Recall
Potential for positively biased results in QC and patient samples.
FDA Determined
Cause 2
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

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.