Disposable Sampling Tube (Krishe) – FDA Validation Missing (2021)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
Brand
Krishe Inc
Lot Codes / Batch Numbers
All Lots
Products Sold
All Lots
Krishe Inc is recalling Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert due to Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Recommended Action
Per FDA guidance
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 vipul@krishelimited.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, LA, TX
Page updated: Jan 10, 2026