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U.S. Department of Health and Human Services

Class 3 Device Recall Vitros Universal Wash Reagent

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  Class 3 Device Recall Vitros Universal Wash Reagent see related information
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/
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14650-0881
For Additional Information Contact Sherry Phillips
Manufacturer Reason
for Recall
Label printing irregularities on cartons and/or bottles.
FDA Determined
Cause 2
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.