Kanata, Canada
DNA Genotek Inc. recalls
2 recalls recorded since 2018, most recently on 18 February 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 February 2022
- Reason
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0982-2022, Z-0981-2022
- ORAcollect RNA: ORE-100
- 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, OC
Terminated Class III Medical devices
- Recall started
- 24 June 2020
- Terminated
- 1 November 2021
- Reason
- Reagents were shipped to customers after the Use by data indicated on its labeling.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3004-2020
- PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral s
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.