FDAFebruary 23, 2012device
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 autoimmu...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
What to do
FDA enforcement status: Terminated
Brands named
tosoh biosciencetosoh
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAcimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.2026-05-08
- FDAFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas2026-03-03
- FDASLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.2026-03-03
- FDASLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.2026-03-03
- FDAHydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 980272026-03-03
- FDARevogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 4103002025-12-05
- FDAMeridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay2025-10-07
- FDAMeridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay2025-10-07
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