FDA Enforcement
Class III
Terminated
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.
Recall: Z-2827-2018
·
Reported August 22, 2018
Enforcement
- Recall Number
- Z-2827-2018
- Event ID
- 80482
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- August 22, 2018
- Initiation Date
- June 5, 2018
- Classification Date
- August 15, 2018
- Termination Date
- April 3, 2020
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895, United States
Description
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
Distribution of unapproved product labeling
Code Info
rev: 6.0-040418
Distribution
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Quantity
9 CDS