Device recall
Z-0382-2022: Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive…
FDA device recall · Class II · Clark Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0382-2022 |
|---|---|
| Recall event | 89088 |
| Product | Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440 |
| Product code | MJH |
| Recalling firm | Clark Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2023 |
| 510(k) numbers | K991074 |
| FEI number | 1318354 |
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