Tosoh Bioscience AIA Analyte Application Manual — Class III medical device recall Z-2827-2018
Terminated recall by Tosoh Bioscience Inc, reported 2018-08-22, distributed in FL, MA, MT, OK, OR, WI. Distribution of unapproved product labeling
| Recall number | Z-2827-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2018-06-05 |
| Classified | 2018-08-15 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2020-04-03 |
| Distributed | FL, MA, MT, OK, OR, WI |
| Quantity | 9 cds |
| Reason classes | labeling, unapproved product |
| Model numbers | 997027CD |
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.
Reason for recall
Distribution of unapproved product labeling
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2827-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.