Device recall
Z-0637-2022: LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk"…
FDA device recall · Class III · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0637-2022 |
|---|---|
| Recall event | 89412 |
| Product | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L. |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 22, 2022 |
| 510(k) numbers | K861022 |
| FEI number | 2150138 |
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