# FDA recall Z-0402-2021

> **Microbiologics Inc** · Class II · device recall initiated 2020-10-08.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-0402-2021
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-08
- **Report date:** 2020-11-11
- **Termination date:** 2022-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2021

## Citation

> AI Analytics. FDA recall Z-0402-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0402-2021. Source: US FDA. Licensed CC0.

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