Tosoh Bioscience Inc recalls Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals fo…

Recall date

June 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2827-2018

FDA classification

Class III

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

US Distribution to states of: FL, MA, MT, OK, OR and WI.

Why it was recalled

Distribution of unapproved product labeling

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.