Oral DNA Collection Device Recalled for Evaporating Stabilizing Liquid
DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.
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 an FDA Class II recall for a product-stability and shelf-life issue with no reported illnesses or injuries documented in the source. The evaporation of stabilizing liquid is a quality concern that may affect device performance but does not pose documented direct health harm.
Plain-English summary
DNA Genotek Inc. is recalling multiple lot numbers of the ORAcollect Dx, an oral DNA collection device used to collect and stabilize DNA samples for laboratory testing.
The device contains a stabilizing liquid that can evaporate over time. When this liquid evaporates, the shelf life of the device is reduced, which may affect the stability and preservation of DNA samples collected in the device.
The recall affects approximately 2,375,514 units distributed in the United States and internationally to countries including Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.
Consumers and healthcare providers should check the lot numbers on affected devices against the list of recalled lots provided by the FDA. Devices with affected lot numbers should not be used.
The recalled product
- Product
- ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
- Manufacturer
- DNA Genotek Inc.
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 (20)
- 627595000309 01006275950003091722091210XI512
- Lot XI512 627595000309 01006275950003091722091310XI513
- Lot XI513 627595000309 01006275950003091722091410XI514
- Lot XI514 627595000309 01006275950003091722091610XI519
- Lot XI519 627595000309 01006275950003091722091610XI520
- Lot XI520 627595000309 01006275950003091722091710XI521
- Lot XI521 627595000309 01006275950003091722091810XI522
- Lot XI522 627595000309 01006275950003091722093010XI534
- Lot XI534 627595000309 01006275950003091722102810XJ536
- Lot XJ536 627595000309 01006275950003091722102810XJ537
- Lot XJ537 627595000309 01006275950003091722111510XK518
- Lot XK518 627595000309 01006275950003091722111610XK519
- Lot XK519 627595000309 01006275950003091722120310XL503
- Lot XL503 627595000309 01006275950003091722120310XL506
- Lot XL506 627595000309 01006275950003091722120410XL510
- Lot XL510 627595000309 01006275950003091722120510XL511
- Lot XL511 627595000309 01006275950003091722120610XL512
- Lot XL512 627595000309 01006275950003091722121410XL521
- Lot XL521 627595000309 01006275950003091722121510XL522
- Lot XL522 627595000309 01006275950003091722123110XL535
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.
See all →- ModerateOral RNA Collection Kit Recalled Due to Stabilizer Evaporation
FDA (Devices) · 2022-04-27
- LowDNA Genotek PrepIT Q2A Kit Recalled for Expired Reagents
FDA (Devices) · 2020-09-30
Other medical device recalls
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
Similar recalls
- HighAlere Recalls Oral Fluid Drug Screen Devices Due to Choking Risk
FDA (Devices) · 2014-01-15
- HighIllumina NextSeq 550Dx DNA Analyzer Recalled for Short Circuit Risk
FDA (Devices) · 2022-04-06
- SevereBio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes
FDA (Devices) · 2019-07-10
- ModerateLife Technologies Recalls Oncomine Dx Target Test DNA Control-IVD
FDA (Devices) · 2020-04-22
- HighLife Technologies Recalls Oncomine Dx Target Test Due to False Negative Risk
FDA (Devices) · 2018-05-02
- ModerateLife Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error
FDA (Devices) · 2020-04-22