FDAFDA · Food and drugs·Recall number Z-1819-2024
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
Published May 22, 2024 · Recall initiated: April 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- QUIDELORTHO
- Distributor
- 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
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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