Catalog 02145P — Class II medical device recall Z-0402-2021
Terminated recall by Microbiologics Inc, reported 2020-11-11, distributed nationwide. Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
| Recall number | Z-0402-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-10-08 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2022-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CL, CN, DE, GB, IE, IN, JP, PH, VN |
| Quantity | 46 units |
| UPC / GTIN / UDI-DI | 20845357040446 |
| Lot numbers | 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 |
| Model numbers | 01245P, 02145P |
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 for recall
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0402-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.