FDA recall Z-2827-2018

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.

Reason for recall

Distribution of unapproved product labeling

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-06-05

Report date

2018-08-22

Termination date

2020-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2827-2018