Recall Z-1422-2021— Krishe Inc

Name: FDA recall Z-1422-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-11

Class II · Terminated

Class II FDA medical device recall by Krishe Inc, initiated 2021-03-11, terminated 2022-11-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE. Reason: Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing.

Recalling firm: Krishe Inc
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Terminated: 2022-11-16
Firm location: Plano, TX, United States

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.