Device recall
Z-2200-2019: HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For…
FDA device recall · Class II · Hycor Biomedical Inc
Key facts
| Recall number (Z-number) | Z-2200-2019 |
|---|---|
| Recall event | 83268 |
| Product | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC… |
| Product code | DHR |
| Recalling firm | Hycor Biomedical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K994338 |
| FEI number | 1000125787 |
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