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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS DAT Performance Verifier IV

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  Class 2 Device Recall VITROS DAT Performance Verifier IV see related information
Date Initiated by Firm September 22, 2017
Create Date March 06, 2018
Recall Status1 Terminated 3 on August 24, 2020
Recall Number Z-0914-2018
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 IV in vitro diagnostic
Code Information Catalog# 6802330 Lot# L5619
Recalling Firm/
Ortho-Clinical Diagnostics
1000 Lee Road
Rochester NY 14606
For Additional Information Contact Joe Falvo
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 2
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 196
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 and Original Applicant = ORTHO-CLINICAL DIAGNOSTICS
510(K)s with Product Code = DIF and Original Applicant = Ortho-Clinical Diagnostics, Inc.