Device recall
Z-1222-2018: QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated…
FDA device recall · Class II · Inova Diagnostics Incorporated
Key facts
| Recall number (Z-number) | Z-1222-2018 |
|---|---|
| Recall event | 79380 |
| Product | QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting… |
| Product code | JJE |
| Recalling firm | Inova Diagnostics Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2018 |
| FEI number | 2026994 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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