medical Class II Updated 2018-06-13

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

Recalled Product

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


Hazard / Issue

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lot Codes
View official government recall

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