Device product
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Z-1422-2021
Product summary
- Firm
- Krishe Inc
- Event
- Event 87595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,000 units
- Official record key
device-enforcement:Z-1422-2021
Official wording
Reason: Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Code information: All Lots
Distribution pattern: US: LA, TX, FL, GA
Derived failure modes
-
Unknown
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing