Device recall
Z-0283-2019: Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media…
FDA device recall · Class III · Acumedia Manufacturers, Inc.
Key facts
| Recall number (Z-number) | Z-0283-2019 |
|---|---|
| Recall event | 81115 |
| Product | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of… |
| Product code | JSI |
| Recalling firm | Acumedia Manufacturers, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 18, 2020 |
| FEI number | 1120041 |
At a glance
- None 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