FDA Medical Device Recalls (openFDA)
DNA Genotek Inc.: ORAcollect RNA: ORE-100
- Recall number
- Z-0982-2022
- Recalling firm
- DNA Genotek Inc.
- Product
- ORAcollect RNA: ORE-100
- Status
- Open, Classified
- Initiated
- 2022-02-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- Evaporation of stabilizing liquid reducing shelf life.
- Root cause
- Nonconforming Material/Component
- Action
- Notification emailed to customers 2/18/2022. The shelf-life "Collect sample by/Use by" date found on the collection device tube label has been reduced by 12 months. Contact firm if unable to recover the minimum input volume required for sample extraction. Submit online acknowledgement form and contact your DNA Genotek Account manager or Technical Services with questions: support@dnagenotek.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lot: YJ530
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3003742580
- Firm city
- Kanata
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28