Class 3 Device Recall Vitros Universal Wash Reagent

• Date Initiated by Firm: January 10, 2003
• Date Posted: February 21, 2003
• Recall Status: Terminated 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
• FEI Number: 1000136573
• 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: 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 =