VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589
This recall is currently active, issued May 14, 2024. It was issued by Quidelortho.
- Company
- Quidelortho
- Recall Initiated
- April 9, 2024
- Posted
- May 14, 2024
- Recall Number
- Z-1818-2024
- Quantity
- 21268 units
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
T3 Reagent Packs used with Free T3 Calibrators 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.
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.
Lot / Code Info
UDI-DI: 10758750008797 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
Root Cause
Under Investigation by firm
Action Taken
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.