FDA Device recall Z-0402-2021
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of…
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of… by Microbiologics, citing strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0402-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-08 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microbiologics |
| Distribution | US |
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.
Reason
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
Identifiers
| code_info | Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0402-2021%22
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