Class 2 Device Recall VITROS DAT Performance Verifier I

• Date Initiated by Firm: September 22, 2017
• Create Date: March 06, 2018
• Recall Status: Terminated on August 24, 2020
• Recall Number: Z-0911-2018
• Recall Event ID: 79155
• 510(K)Number: K062077 K062165
• Product Classification: Drug mixture control materials - Product Code DIF
• Product: VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
• Code Information: Catalog# 6802327 Lot# H5616
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 1000 Lee Road; Rochester NY 14606
• For Additional Information Contact: Joe Falvo; 585-724-2210
• Manufacturer Reason for Recall: This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
• FDA Determined Cause: Under Investigation by firm
• Action: On September 18, 2017 a letter was sent to customers who received the BENZ reagent within the past 18 months of affected lots. The letter stated that customers may continue use of the product if QC results using VITROS DAT Performance Verifiers are within established ranges for each assay. If QC BENZ results are below established ranges, the customer should discontinue use of the product. The letter requests customers post the notification by each system that processes the VITROS BENZ Reagent. If the product was transferred outside of the facility, to notify those customers as well. Affected lots will be replaced in 6-8 weeks. Questions or concerns can be directed to 585-453-3452
• Quantity in Commerce: 349
• Distribution: Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
• 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 = DIF; 510(K)s with Product Code = DIF