Drug recall
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012…
FDA recall event 89831 · Class II · DNA Genotek Inc.
Key facts
| Event ID | 89831 |
|---|---|
| Recall numbers | Z-0981-2022, Z-0982-2022 |
| Recalling firm | DNA Genotek Inc. |
| Product type | Devices |
| Products | 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…, ORAcollect RNA: ORE-100 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Evaporation of stabilizing liquid reducing shelf life. |
| Initiation date | Feb 18, 2022 |
| Report date | Apr 27, 2022 |
| City | Kanata |
| Country | Canada |
| FEI number | 3003742580 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: