FDA Medical Device Recalls (openFDA)
Tosoh Bioscience Inc: 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 number
- Z-2827-2018
- Recalling firm
- Tosoh Bioscience Inc
- 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.
- Status
- Terminated
- Initiated
- 2018-06-05
- Posted
- not on file
- Terminated
- 2020-04-03
- Reason
- Distribution of unapproved product labeling
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 9 CDS
- Distribution
- US Distribution to states of: FL, MA, MT, OK, OR and WI.
- Lot, serial or model codes
- rev: 6.0-040418
- 510(k) numbers
- ["K111335","K121533","K981521","K981522"]
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 3005529799
- Firm city
- Grove City
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28