Device recall
Z-2134-2019: AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid…
FDA device recall · Class II · Hycor Biomedical Inc
Key facts
| Recall number (Z-number) | Z-2134-2019 |
|---|---|
| Recall event | 82952 |
| Product | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM… |
| Product code | DHR |
| Recalling firm | Hycor Biomedical Inc |
| Recall class | Class II |
| Status | Completed |
| 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