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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products Performance Verifier II

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  Class 3 Device Recall VITROS Chemistry Products Performance Verifier II see related information
Date Initiated by Firm October 16, 2020
Create Date November 18, 2020
Recall Status1 Open3, Classified
Recall Number Z-0471-2021
Recall Event ID 86669
510(K)Number K904768  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
Code Information Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577 
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact SAME
908-218-1300
Manufacturer Reason
for Recall		 Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
FDA Determined
Cause 2		 Under Investigation by firm
Action Ortho Clinical Diagnostics issued letter IMPORTANT PRODUCT CORRECTION NOTIFICATION (CL2020-243) on 16 October 2020 via FedEx/US Priority Mail or ORTHO Plus e-Communications for delivery on October 19, 2020, stating reason for recall, health risk and action to take: If their laboratory used VITROS Performance Verifier II Lot Q7692 to verify performance of VITROS ALKP Slides and stores an inventory of unopened vials in the refrigerator: Discard any remaining refrigerated inventory of unopened VITROS Performance Verifier II Lot Q7692. If their laboratory does not store inventory of VITROS Performance Verifier II Lot Q7692 in the refrigerator or does not use Lot Q7692 to verify performance of VITROS ALKP Slides: No Action Is Required. To verify performance of VITROS ALKP Slides, use frozen (never refrigerated) inventory of VITROS Performance Verifier II Lot Q7692 or switch to another lot of VITROS Performance Verifier II. Ortho will replace or credit your account as indicated on your Confirmation of Receipt form Retain this notification as verification of the revised instructions. OUS notified by email on 09/14/20 to global affiliates for distribution to distributors and customers.
Quantity in Commerce 10788 total: US 4680; OUS 6108
Distribution Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = EASTMAN KODAK COMPANY
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