Home / Recalls / Krishe Inc / Z-1422-2021

Z-1422-2021 Class II Terminated

Recalled by Krishe Inc — Plano, TX

Recall Details

Product Type
Devices
Report Date
April 21, 2021
Initiation Date
March 11, 2021
Termination Date
November 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,000 units

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

Distribution Pattern

US: LA, TX, FL, GA

Code Information

All Lots

Other recalls by Krishe Inc

  • Z-1421-2021 Class II — Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal (March 11, 2021)
  • Z-1420-2021 Class II — Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab (March 11, 2021)
  • Z-1423-2021 Class II — Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, (March 11, 2021)