Medical device recalls Moderate risk

Krishe Inc recalls Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

Recall date
March 11, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1423-2021
FDA classification
Class II
Brand / firm
Krishe Inc
Sold / distributed
US: LA, TX, FL, GA

Why it was recalled

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

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