Drug recall
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert…
FDA recall event 87595 · Class II · Krishe Inc
Key facts
| Event ID | 87595 |
|---|---|
| Recall numbers | Z-1420-2021, Z-1421-2021, Z-1422-2021, Z-1423-2021 |
| Recalling firm | Krishe Inc |
| Product type | Devices |
| Products | Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE, Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE, Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R, Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
| Initiation date | Mar 11, 2021 |
| Report date | Apr 21, 2021 |
| Termination date | Nov 16, 2022 |
| City | Plano |
| State | TX |
| Country | United States |
| FEI number | 3018098283 |
At a glance
- 1–9 Products in this recall
- None 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: