FDA-Device2018-06-13Class II
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
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
1358
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2074-2018Don't want to check this manually?
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