Class 3 Device Recall Vitros

• Date Initiated by Firm: March 26, 2003
• Date Posted: June 05, 2003
• Recall Status: Terminated on November 16, 2004
• Recall Number: Z-0919-03
• Recall Event ID: 26148
• 510(K)Number: K812028
• Product Classification: Biuret (Colorimetric), Total Protein - Product Code CEK
• Product: Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
• Code Information: All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.
• FEI Number: 1000136573
• 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: Slides may exhibit random, elevated imprecision of results.
• FDA Determined Cause: Other
• Action: Notification via letter dated 3/26/03 with instructions to discard product.
• Quantity in Commerce: 29,273 (domestic); 4,967 (international)
• Distribution: Nationwide and Worldwide.
• Total Product Life Cycle: TPLC Device Report

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 = CEK