FDA-Device2018-06-13Class II
ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
Tosoh Bioscience Inc
Hazard
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Sold states
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Affected count
3406
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2018Don't want to check this manually?
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