FDAApril 9, 2024device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
quidelortho
UPCs
10758750008797
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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