CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
Disposable Sampling Tube recalled by Krishe
Krishe is recalling Disposable Sampling Tube, distributed in Florida, Georgia, Louisiana, Texas. The recall was initiated on 11 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1420-2021
- FDA event ID
- 87595
- Recalling firm
- Krishe, Plano, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2021
- FDA classified
- 13 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2021 | Recall initiated by company | |
| 13 Apr 2021 | Classified by FDA | +33 days |
| 21 Apr 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
Where it was distributed
US: LA, TX, FL, GA
Questions about this recall
Is Disposable Sampling Tube recalled?
Yes. Krishe recalled Disposable Sampling Tube on 11 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1420-2021.
Why was it recalled?
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Which lots are affected?
All Lots
Where was it sold?
US: LA, TX, FL, GA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Krishe
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dasky Disposable Sampling Tube recalled by Krishe | Krishe | Sterility | 4 states |
| Device | CLASS II | Dasky Disposable Sampling Tube recalled by Krishe | Krishe | Sterility | 4 states |
| Device | CLASS II | Dasky Disposable Sampling Tube recalled by Krishe | Krishe | Packaging Defects | 4 states |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |