FDAApril 9, 2024device
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
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
quidelortho
UPCs
10758750008438
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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