PlainRecalls
FDA Devices Moderate Class II Ongoing

ORAcollect RNA: ORE-100

Reported: April 27, 2022 Initiated: February 18, 2022 #Z-0982-2022

Product Description

ORAcollect RNA: ORE-100

Reason for Recall

Evaporation of stabilizing liquid reducing shelf life.

Details

Recalling Firm
DNA Genotek Inc.
Units Affected
17,080 (US: 14, 17,066)
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.
Location
Kanata

Frequently Asked Questions

What product was recalled?
ORAcollect RNA: ORE-100. Recalled by DNA Genotek Inc.. Units affected: 17,080 (US: 14, 17,066).
Why was this product recalled?
Evaporation of stabilizing liquid reducing shelf life.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0982-2022.