# FDA recall Z-3004-2020

> **DNA Genotek Inc.** · Class III · device recall initiated 2020-06-24.

## Product

PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

## Reason for recall

Reagents were shipped to customers after the  Use by  data indicated on its labeling.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.

## Key facts

- **Recall number:** Z-3004-2020
- **Recalling firm:** DNA Genotek Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-24
- **Report date:** 2020-09-30
- **Termination date:** 2021-11-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3004-2020

## Citation

> AI Analytics. FDA recall Z-3004-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3004-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*