# FDA recall Z-0982-2022

> **DNA Genotek Inc.** · Class II · device recall initiated 2022-02-18.

## Product

ORAcollect RNA: ORE-100

## Reason for recall

Evaporation of stabilizing liquid reducing shelf life.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.

## Key facts

- **Recall number:** Z-0982-2022
- **Recalling firm:** DNA Genotek Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-18
- **Report date:** 2022-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kanata, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2022

## Citation

> AI Analytics. FDA recall Z-0982-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0982-2022. Source: US FDA. Licensed CC0.

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