Z-1420-2021Class II

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

Name: Z-1420-2021 Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1...
Creator: Krishe Inc
Published: 2021-03-11
License: https://open.fda.gov/license/

Krishe Inc / initiated 2021-03-11 / Terminated

FDA source

Krishe Inc began a recall of Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE on 2021-03-11. FDA classified it as Class II and gives the reason as "Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1420-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Posted: 2021-04-13
Terminated: 2022-11-16
Recalling firm: Krishe Inc
Product: Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
Product code: JSM Culture Media, Non-Propagating Transport
Reason for recall: Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
FDA root cause: Other
Action: Krishe sent a "Urgent: Medical Device Recall" dated 3/11/21 via to all affected consignees via Fed Ex. In addition to informing consignees about the recall the firm ask consignees to take the following actions: 1. If you have any of the virus transport medium tubes, please immediately stop selling and using them. Please place them in quarantine and follow the instruction for return and credit that accompany this letter. 2. Please complete the attached acknowledgement and receipt form and return within 5 business days. If you do not have any of the recall product, we ask that you still completed the form and return it within 5 days. 3. If you have any questions, or for a return authorization, please contact Vipul Tailor, via telephone at 734-748-9580 or email [email protected]. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse event Reporting program either online by regular mail or by fax.
Quantity in commerce: 1,700,000 units
Distribution: US: LA, TX, FL, GA
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1420-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1420-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-13
Z-1421-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-13
Z-1422-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-13
Z-1423-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-13

Product code JSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)