medical Class III Updated 2018-08-22

Tosoh Bioscience Inc recalls Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Pa

Recalled Product

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.

Hazard / Issue

Distribution of unapproved product labeling

Issued by

FDA

Affected States: FL, MA, MT, OK, OR, WI
Lot/Code Info: rev: 6.0-040418
View official government recall

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