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Tosoh Bioscience Inc recalls ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Recalled June 13, 2018 · FDA recall Z-2089-2018 · Tosoh Bioscience
Hazard
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. · FDA Class II
Units
49
Sold at
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Description
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Product
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →