Tosoh Bioscience Inc recalls ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker

Recalled June 13, 2018 · FDA recall Z-2073-2018 · 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

5802

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 cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker

Manufacturer(s)

Tosoh Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →