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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Performance Verifier II

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  Class 3 Device Recall VITROS Performance Verifier II see related information
Date Initiated by Firm July 10, 2017
Create Date March 01, 2018
Recall Status1 Terminated 3 on August 06, 2020
Recall Number Z-0807-2018
Recall Event ID 78724
510(K)Number K042006  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information Lot K4852, Expiration 22 Feb 2018
Recalling Firm/
Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact Joe Falvo
Manufacturer Reason
for Recall
VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action On July 10, 2017 the firm sent notification letters and an e-communications to their customers. Foreign customers were notified by email. Customers were instructed to complete a response form with the amount of product on hand and to discontinue use of the recalled product. For further questions, please call (585) 453-3452.
Quantity in Commerce 10,021 units
Distribution 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 = JJY and Original Applicant = Ortho-Clinical Diagnostics, Inc.