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.
This recall has been terminated (originally issued June 5, 2018).
- Company
- Tosoh Bioscience Inc
- Recall Initiated
- June 5, 2018
- Terminated
- April 3, 2020
- Recall Number
- Z-2827-2018
- Quantity
- 9 CDS
- Firm Location
- Grove City, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Distribution of unapproved product labeling
Distribution
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Lot / Code Info
rev: 6.0-040418
Root Cause
Error in labeling
Action Taken
The firm, Tosoh Bioscience, notified customers via a phone call on May 29, 2018 and May 31, 2018, reference "Product Labeling-Removal". The phone call described the product, problem and actions to be taken. The firm instructed to confirm receipt of the CD containing AAMs; return the unapproved labeling; if printouts were made of any information on the CD then destroy it, if not, thank customer for response and complete the Customer Call form. The firm will provide the Customers updated CD following approval and release. Any further questions, contact Sr. QA Manager at 614-317-1909 or email: Levent.durukan@tosoh.com.