Recall Z-1420-2021 ยท JSM Culture Media, Non-Propagating Transport
Krishe Inc
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
| Date | Mar 11, 2021 |
| Status | Terminated |
| Reason | Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing |
| Root cause | 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 c |
| Quantity | 1,700,000 units |
| Distribution | US: LA, TX, FL, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.