PlainRecalls
FDA Devices Moderate Class II Terminated

Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE

Reported: April 21, 2021 Initiated: March 11, 2021 #Z-1421-2021

Product Description

Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 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

Details

Recalling Firm
Krishe Inc
Units Affected
441,500 units
Distribution
US: LA, TX, FL, GA
Location
Plano, TX

Frequently Asked Questions

What product was recalled?
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE. Recalled by Krishe Inc. Units affected: 441,500 units.
Why was this product recalled?
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Which agency issued this recall?
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1421-2021.