Recall Z-0981-2022— DNA Genotek Inc.
Class II · Ongoing
Class II FDA medical device recall by DNA Genotek Inc., initiated 2022-02-18. It names one FDA 510(k) clearance: K152464. 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. Reason: Evaporation of stabilizing liquid reducing shelf life..
- Recalling firm
- DNA Genotek Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-18
- Firm location
- Kanata, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Evaporation of stabilizing liquid reducing shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.