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.
What this means for you
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.
- Hazard
- evaporation
- shelf-life-reduction
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
Distributed nationwide across the United States.
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