Dasky Disposable Sampling Tube — Class II medical device recall Z-1422-2021
Terminated recall by Krishe Inc, reported 2021-04-21, distributed in FL, GA, LA, TX. Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and mark
| Recall number | Z-1422-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Krishe Inc, Plano, TX, United States |
| Recall initiated | 2021-03-11 |
| Classified | 2021-04-13 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2022-11-16 |
| Distributed | FL, GA, LA, TX |
| Quantity | 18,000 units |
| Model numbers | VSM03 |
Product
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Reason for recall
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1422-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.