Medical device recalls Moderate risk

Tosoh Bioscience Inc recalls AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human…

Recall date
November 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0672-2019
FDA classification
Class II
Brand / firm
Tosoh Bioscience Inc
Sold / distributed
US Nationwide

What was recalled

AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.

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