Drug recall
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls…
FDA recall event 86574 · Class II · Microbiologics Inc
Key facts
| Event ID | 86574 |
|---|---|
| Recall numbers | Z-0402-2021 |
| Recalling firm | Microbiologics Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. |
| Initiation date | Oct 8, 2020 |
| Report date | Nov 11, 2020 |
| Termination date | Nov 3, 2022 |
| City | Saint Cloud |
| State | MN |
| Country | United States |
| FEI number | 2150138 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: