Krishe Inc FDA Recalls

4 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CEClass IIMar 11, 2021Verification and validation of the virus transport medium tu	Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and mark	Class IIDevices	Mar 11, 2021
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile RClass IIMar 11, 2021Verification and validation of the virus transport medium tu	Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and mark	Class IIDevices	Mar 11, 2021
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVClass IIMar 11, 2021Verification and validation of the virus transport medium tu	Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and mark	Class IIDevices	Mar 11, 2021
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CEClass IIMar 11, 2021Verification and validation of the virus transport medium tu	Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and mark	Class IIDevices	Mar 11, 2021