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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products Free T3 Calibrators

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  Class 2 Device Recall VITROS Immunodiagnostic Products Free T3 Calibrators see related information
Date Initiated by Firm April 09, 2024
Date Posted May 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1819-2024
Recall Event ID 94436
510(K)Number K994145  
Product Classification Calibrator, primary - Product Code JIS
Product VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820
Code Information UDI-DI: 10758750008438 Lot Numbers: 3042 Expiry: 09-Apr-2024; 3052 Expiry: 02-May-2024; 3061 Expiry: 06-Jun-2024; 3080 Expiry: 02-May-2024; 3090 Expiry: 14-Jun-2024; 3100 Expiry: 29-Jul-2024; 3110 Expiry: 13-Aug-2024; 3126 Expiry: 04-Sep-2024
Recalling Firm/
Manufacturer		 QUIDELORTHO
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		 Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
FDA Determined
Cause 2		 Under Investigation by firm
Action QuidelOrtho issued Important Product Correction Notification issued April 9, 2024. Letter states reason for recall, health risk and action to take: Discontinue using, render unusable, and discard affected lots of VITROS Free T3 Reagent Pack (and associated calibrators). " Complete the enclosed Confirmation of Receipt form no later than April 17, 2024. Upon receipt of your completed form, QuidelOrtho will provide credit for, or replacement of, discarded product. " Save this notification with your User Documentation or post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution QuidelOrtho s investigation is on-going, and currently working to identify root cause. Contact Global Services Organization at 1-800-421-3311.
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, 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 = JIS and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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