FDA-Device2018-06-13Class II
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
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
4867
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief