Device recall
Z-0546-2022: KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected…
FDA device recall · Class III · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0546-2022 |
|---|---|
| Recall event | 89384 |
| Product | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM) |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 12, 2023 |
| 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