Device recall
Z-0678-2022: meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit…
FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Recall number (Z-number) | Z-0678-2022 |
|---|---|
| Recall event | 89493 |
| Product | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated… |
| Product code | LIQ |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2023 |
| 510(k) numbers | K971585 |
| FEI number | 1417592 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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