AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoas...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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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