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
Check against the official notice below — it lists the full affected range.
DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection kits (catalog numbers OCD-100 and OCD-100A) due to evaporation of the stabilizing liquid in the collection tubes, which reduces the shelf life of the product. Approximately 2.3 million kits have been distributed worldwide, including 2.1 million units throughout the United States and additional units in Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Denmark, Finland, Germany, Great Britain, Italy, Japan, the Netherlands, South Africa, and Thailand.
The affected kits are identified by specific lot codes including XI512 through XI534, XJ536 through XJ537, XK518 through XK519, XL503 through XL512, XL521 through XL522, XL535, and YA501 through YA532, among others listed in the recall notice. The source does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Evaporation of stabilizing liquid reducing shelf life.
Reason for recall: Evaporation of stabilizing liquid reducing shelf life. 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 Thail Quantity: 2,375,514 (US: 2,148,222 OUS: 227,292) Lot/code info: 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, Lot XL535 627595000309 01006275950003091723010410YA501, Lot YA501 627595000309 01006275950003091723011110YA510, Lot YA510 627595000309 01006275950003091723011510YA515, Lot YA515 627595000309 01006275950003091723011610YA516, Lot YA516 627595000309 01006275950003091723013010YA531, Lot YA531 627595000309 01006275950003091723013110YA532, Lot YA532 627595000309 01006275950003091723021510YB522
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.