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U.S. Department of Health and Human Services

Class 3 Device Recall Vitros

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  Class 3 Device Recall Vitros see related information
Date Initiated by Firm December 18, 2002
Date Posted February 21, 2003
Recall Status1 Terminated 3 on April 14, 2003
Recall Number Z-0557-03
Recall Event ID 25319
510(K)Number K013899  
Product CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
Code Information T3606, Exp 31 Mar 2004
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14650-0881
For Additional Information Contact Sherry L. Phillips
Manufacturer Reason
for Recall
Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
FDA Determined
Cause 2
Action Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.
Quantity in Commerce 1,338 cartons
Distribution Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).

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 = and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS