# FDA recall Z-1422-2021

> **Krishe Inc** · Class II · device recall initiated 2021-03-11.

## 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

## Distribution

US: LA, TX, FL, GA

## Key facts

- **Recall number:** Z-1422-2021
- **Recalling firm:** Krishe Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-11
- **Report date:** 2021-04-21
- **Termination date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plano, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1422-2021

## Citation

> AI Analytics. FDA recall Z-1422-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1422-2021. Source: US FDA. Licensed CC0.

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