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Tosoh Bioscience Inc recalls Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals
Recalled August 22, 2018 · FDA recall Z-2827-2018 · Tosoh Bioscience
Hazard
Distribution of unapproved product labeling · FDA Class III
Units
9 CDS
Sold at
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Description
Distribution of unapproved product labeling
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.
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →