Plano, TX, United States
Krishe Inc recalls
1 recall recorded since 2018, most recently on 11 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 March 2021
- Terminated
- 16 November 2022
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1421-2021, Z-1422-2021, Z-1423-2021, Z-1420-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.