Device recall
Z-0402-2021: Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0402-2021 |
|---|---|
| Recall event | 86574 |
| Product | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate. |
| Product code | JTR |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 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