| Class 3 Device Recall VITROS Chemistry Products Performance Verifier II | |
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
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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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJY
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