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

Agency Publication Date: April 13, 2021

Affected Products

Product: Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

All Lots

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

All Lots

Product: Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE

All Lots

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

All Lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87595

Status: Resolved

Manufacturer: Krishe Inc

Manufactured In: United States

Units Affected: 4 products (1,700,000 units; 441,500 units; 18,000 units; 10,000 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Medium RiskFDA Device

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

Agency Publication Date: April 13, 2021

Affected Products

Product: Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

All Lots

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

All Lots

Product: Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE

All Lots

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

All Lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87595

Status: Resolved

Manufacturer: Krishe Inc

Manufactured In: United States

Units Affected: 4 products (1,700,000 units; 441,500 units; 18,000 units; 10,000 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

Sources: FDA iRES · Raw API Response