Krishe Inc Recall 87595
Description: Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Krishe Inc Recall 87595 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1421-2021 |
| Event ID | 87595 |
| Event Description | Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE |
| Product Type | Devices |
| Distribution | US: LA, TX, FL, GA |
| Quantity | 441,500 units |
| Recall Reason | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
| Device Classification | 20210421 |
| Device Code Info | All Lots |
| Center Classification Date | 20210413 |
| Recall Initiation Date | 20210311 |
| Recalling Firm | Krishe Inc |
| Initial Notification | Letter |
| Similar To |