Oral RNA Collection Kit Recalled Due to Stabilizer Evaporation
DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported adverse events. The hazard is shelf-life reduction due to stabilizer evaporation, a product-quality defect rather than an explicit safety risk. Per the rubric, recalls with theoretical hazards and no reported illness qualify as Moderate.
Plain-English summary
DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100, an oral rinse collection kit for sample collection and preservation. Approximately 17,080 units are affected, with 14 units in the United States and 17,066 units distributed internationally.
The recall was initiated due to evaporation of the stabilizing liquid in the kit during storage, which reduces the product's shelf life. The affected lot is YJ530.
In the United States, the product was distributed nationwide across all 50 states and Puerto Rico. Internationally, the product was distributed to Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.
Customers with ORAcollect RNA: ORE-100 kits from lot YJ530 should contact DNA Genotek Inc. for guidance on the recalled product.
The recalled product
- Product
- ORAcollect RNA: ORE-100
- Manufacturer
- DNA Genotek Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: YJ530
Distribution
Part of a larger recall action
This product is one of 2 recalled by DNA Genotek Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · DNA Genotek Inc.
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