Device 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.
Z-2827-2018
Product summary
- Event
- Event 80482
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9 CDS
- Official record key
device-enforcement:Z-2827-2018
Official wording
Reason: Distribution of unapproved product labeling
Code information: rev: 6.0-040418
Distribution pattern: US Distribution to states of: FL, MA, MT, OK, OR and WI.
Derived failure modes
-
Unknown
Distribution of unapproved product labeling