Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN Recalled by Tosoh Bioscience Inc Due to Some combinations of Calibrator lots and AlA 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 Tosoh Bioscience Inc directly.
Affected Products
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Quantity: 34 boxess/2 sets/6 bottles
Why Was This Recalled?
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tosoh Bioscience Inc
Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report