Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ORAcollect Dx Recalled by DNA Genotek Inc. Due to Evaporation of stabilizing liquid reducing shelf life.

Date: February 18, 2022
Company: DNA Genotek Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DNA Genotek Inc. directly.

Affected Products

ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

Quantity: 2,375,514 (US: 2,148,222 OUS: 227,292)

Why Was This Recalled?

Evaporation of stabilizing liquid reducing shelf life.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DNA Genotek Inc.

DNA Genotek Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report