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
- Recall Number
- Z-2827-2018
- Event Number
- 80482
- Firm
- Tosoh Bioscience Inc
- FEI Number
- 3005529799
- Product Code
- JIX
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- June 5, 2018
- Terminated
- April 3, 2020
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895
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.
Distribution of unapproved product labeling
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: [email protected].
US Distribution to states of: FL, MA, MT, OK, OR and WI.
9 CDS