Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87595

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 11, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Krishe Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1420-2021
Recall number
Z-1420-2021
Initiated
March 11, 2021
Classification
Class II
Status
Terminated
Recalling firm
Krishe Inc
Quantity
1,700,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots

Distribution pattern

US: LA, TX, FL, GA

device · product 2 of 4

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

Z-1421-2021
Recall number
Z-1421-2021
Initiated
March 11, 2021
Classification
Class II
Status
Terminated
Recalling firm
Krishe Inc
Quantity
441,500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots

Distribution pattern

US: LA, TX, FL, GA

device · product 3 of 4

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

Z-1422-2021
Recall number
Z-1422-2021
Initiated
March 11, 2021
Classification
Class II
Status
Terminated
Recalling firm
Krishe Inc
Quantity
18,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots

Distribution pattern

US: LA, TX, FL, GA

device · product 4 of 4

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

Z-1423-2021
Recall number
Z-1423-2021
Initiated
March 11, 2021
Classification
Class II
Status
Terminated
Recalling firm
Krishe Inc
Quantity
10,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All Lots

Distribution pattern

US: LA, TX, FL, GA

Field note

Send feedback

We'll only use this to respond to your feedback.