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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Sampling Tube

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  Class 2 Device Recall Disposable Sampling Tube see related information
Date Initiated by Firm March 11, 2021
Create Date April 13, 2021
Recall Status1 Terminated 3 on November 16, 2022
Recall Number Z-1421-2021
Recall Event ID 87595
Product Classification Microbial nucleic acid storage and stabilization device - Product Code QBD
Product Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Code Information All Lots
Recalling Firm/
Manufacturer		 Krishe Inc
8105 Razor Blvd Ste 213
Plano TX 75024
For Additional Information Contact Mr. Vipul Tailor
734-748-9580
Manufacturer Reason
for Recall		 Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 441,500 units
Distribution US: LA, TX, FL, GA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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