FDA-Device2018-06-13Class II
AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
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
5293
Manufactured in
3600 Gantz Rd, N/A, Grove City, OH, United States
Products
AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2018Don'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