Recall Z-0982-2022— DNA Genotek Inc.

Name: FDA recall Z-0982-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-18

Class II · Ongoing

Class II FDA medical device recall by DNA Genotek Inc., initiated 2022-02-18. FDA's recall record names no specific 510(k) clearance for this event. Product: ORAcollect RNA: ORE-100. Reason: Evaporation of stabilizing liquid reducing shelf life..

Recalling firm: DNA Genotek Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-02-18
Firm location: Kanata, Canada

Product description

ORAcollect RNA: ORE-100

Reason for recall

Evaporation of stabilizing liquid reducing shelf life.

Data sourced from openFDA. This site is unofficial and independent of the FDA.