Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine Recalled by Ortho-Clinical Diagnostics Due to Total T4 Calibrators and Reagent Packs may have...
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 Ortho-Clinical Diagnostics directly.
Affected Products
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Quantity: 583 units Total (357 units domestically & 226 units internationally)
Why Was This Recalled?
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report