FDA recall Z-2098-2018

Product

ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker

Reason for recall

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

Distribution

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-06-13

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2098-2018