Date Initiated by Firm |
January 10, 2003 |
Date Posted |
February 21, 2003 |
Recall Status1 |
Terminated 3 on June 03, 2003 |
Recall Number |
Z-0558-03 |
Recall Event ID |
25394 |
510(K)Number |
K964310
|
Product |
Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
|
Code Information |
Lot 5003, Exp. 12 September 2003 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester NY 14650-0881
|
For Additional Information Contact |
Sherry Phillips 585-453-3728
|
Manufacturer Reason for Recall |
Label printing irregularities on cartons and/or bottles.
|
FDA Determined Cause 2 |
Other |
Action |
Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print. |
Quantity in Commerce |
284 cartons/2 bottles per carton |
Distribution |
Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A.
No product was shipped outside the U.S. |
|
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 = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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