Device evidence

device-recall:cfres:165573

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.

Official recall number

Z-2827-2018

Evidence summary

Product code: JIX
Recall status: Terminated
Event initiated: June 05, 2018
Root cause: Error in labeling
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2827-2018