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

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

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.