Device recall
Z-2827-2018: Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD…
FDA device recall · Class III · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-2827-2018 |
|---|---|
| Recall event | 80482 |
| 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… |
| Product code | JIX |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 3, 2020 |
| 510(k) numbers | K111335, K121533, K981521, K981522 |
| FEI number | 3005529799 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database