Z-1422-2021 Class II Terminated
FDA device recall Z-1422-2021 was initiated by Krishe Inc on March 11, 2021 and is designated Class II. Reason for recall: Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing The recall status is terminated (terminated November 16, 2022). Affected quantity: 18,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 11, 2021
- Termination Date
- November 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,000 units
Product Description
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Reason for Recall
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Distribution Pattern
US: LA, TX, FL, GA
Code Information
All Lots