Class III — Tosoh Bioscience Inc
| Recalling firm | TOSOH BIOSCIENCE |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Distribution of unapproved product labeling |
| 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. |
| Quantity | 9 CDS |
| Distribution | US Distribution to states of: FL, MA, MT, OK, OR and WI. |
| Initiated | 2018-06-05 |
| Classified | 2018-08-15 |
| Terminated | 2020-04-03 |
| Recall number | Z-2827-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Tosoh Bioscience Inc (Z-2827-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80482/
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