Z-0982-2022Class II

ORAcollect RNA: ORE-100

Name: Z-0982-2022 ORAcollect RNA: ORE-100
Creator: DNA Genotek Inc.
Published: 2022-02-18
License: https://open.fda.gov/license/

DNA Genotek Inc. / initiated 2022-02-18 / Open, Classified / root cause: manufacturing process

FDA source

DNA Genotek Inc. began a recall of ORAcollect RNA: ORE-100 on 2022-02-18. FDA classified it as Class II and gives the reason as "Evaporation of stabilizing liquid reducing shelf life". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0982-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-18
Posted: 2022-04-21
Recalling firm: DNA Genotek Inc.
Product: ORAcollect RNA: ORE-100
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Evaporation of stabilizing liquid reducing shelf life.
Root cause tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 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.
Product codes and lots: Lot: YJ530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0982-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0982-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)