Product Wiki · Recalls · U.S. FDA — Device Enforcement

ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone — recall Z-2089-2018

U.S. FDA — Device Enforcement · United States · 2018-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2089-2018
Date of alert
2018-03-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Tosoh Bioscience Inc
Product category
device
Product type
Devices
Reported risk: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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