# FDA recall Z-2487-2021

> **Microbiologics Inc** · Class II · device recall initiated 2021-08-20.

## Product

SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

## Reason for recall

The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.

## Key facts

- **Recall number:** Z-2487-2021
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-20
- **Report date:** 2021-09-29
- **Termination date:** 2023-01-12

- **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-2487-2021

## Citation

> AI Analytics. FDA recall Z-2487-2021. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2487-2021. Source: US FDA. Licensed CC0.

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