Device recall
Z-0582-2022: KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0582-2022 |
|---|---|
| Recall event | 89391 |
| Product | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a… |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 7, 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