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/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester NY 14650-0881
|
For Additional Information Contact |
Sherry L. Phillips 585-453-3728
|
Manufacturer Reason for Recall |
Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
|
FDA Determined Cause 2 |
Other |
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
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