Class 2 Device Recall VITROS Chemistry Products PHBR Slides

• Date Initiated by Firm: June 23, 2011
• Date Posted: February 28, 2012
• Recall Status: Terminated on May 10, 2016
• Recall Number: Z-1117-2012
• Recall Event ID: 60831
• 510(K)Number: K984288
• Product Classification: Enzyme immunoassay, phenobarbital - Product Code DLZ
• Product: VITROS¿ Chemistry Products PHBR Slides, REF 822 1384 ; --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. ; ; For in vitro diagnostic use only. VITROS¿ Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
• Code Information: Lot numbers: 2532-0053-4961 (exp. 2/01/12), 2532-0053-4984 (exp. 2/01/12), 2532-0053-4996 (exp. 3/01/12), 2532-0053-4997 (exp. 3/01/12), 2532-0053-0144 (exp. 3/01/12), 2532-0053-0149 (exp. 3/01/12), 2532-0053-0217 (exp. 3/01/12), 2532-0053-0615 (exp. 4/01/12), 2532-0053-0616 (exp. 4/01/12), 2532-0053-1472 (exp. 5/01/12), 2532-0053-1488 (exp. 5/01/12), 2532-0053-1489 (exp. 5/01/12), 2532-0053-1490 (exp. 5/01/12) [Note the four middle numbers (0053) of the above Lot #s constitute the Coating #].
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Drive; Rochester NY 14626
• For Additional Information Contact: Ms. Carol Montandon; 908-218-8190
• Manufacturer Reason for Recall: Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS¿ Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Ortho Clinical Diagnostics sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated June 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using and discard all remaining lots of the affected product. A Confirmation of Receipt Form was attached so customers may complete and return to the firm. The firm recommends that customers consult with their Laboratory Medical Director and requesting physician to resolve any concerns they may have regarding previously reported results. Contact Customer Technical Services at 1-800-421-3311 for questions regarding this notification.
• Quantity in Commerce: Domestic - 2345 sale units, Foreign - 632 sales units
• Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
• 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 = DLZ and Original Applicant = Ortho-Clinical Diagnostics, Inc.