Device product
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
Z-1420-2021
Product summary
- Firm
- Krishe Inc
- Event
- Event 87595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,700,000 units
- Official record key
device-enforcement:Z-1420-2021
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