Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Recalled by QUIDELORTHO Due to Free T3 Calibrators used with T3 Reagent Packs...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact QUIDELORTHO directly.
Affected Products
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
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About QUIDELORTHO
QUIDELORTHO has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report