DNA Genotek Inc.: Medical Device Recall in 2022 - (Recall #: Z-0982-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

ORAcollect RNA: ORE-100

Product Classification:

Class II

Date Initiated: February 18, 2022

Date Posted: April 27, 2022

Recall Number: Z-0982-2022

Event ID: 89831

Reason for Recall:

Evaporation of stabilizing liquid reducing shelf life.

Status: Ongoing

Product Quantity: 17,080 (US: 14, 17,066)

Code Information:

Lot: YJ530

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated