Summary
The FDA issued a Class II for ORAcollect RNA: ORE-100 by DNA Genotek Inc.. Reason: Evaporation of stabilizing liquid reducing shelf life..
Details
Source
Device Recall
External ID
Z-0982-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
ORAcollect RNA: ORE-100
Lot/Code Info: Lot: YJ530
Quantity Affected: 17,080 (US: 14, 17,066)
Reason for Recall
Evaporation of stabilizing liquid reducing shelf life.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-18
Company
Kanata
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DNA Genotek Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DNA Genotek Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DNA Genotek Inc. have FDA actions?
DNA Genotek Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0982-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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