Recall Z-0981-2022 ยท OYJ Dna Specimen Collection, Saliva
DNA Genotek Inc.
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
| Date | Feb 18, 2022 |
| Status | Open, Classified |
| Reason | Evaporation of stabilizing liquid reducing shelf life. |
| 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: support@dnagenotek.com. |
| Quantity | 2,375,514 (US: 2,148,222 OUS: 227,292) |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152464 | ORAcollect.Dx DNA Genotek, Inc., May 26, 2016 |