Recall Z-0561-2022 ยท JSM Culture Media, Non-Propagating Transport
Gentueri Inc
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
| Date | Jul 6, 2020 |
| Status | Terminated |
| Reason | Kits failed sterility testing and showed evidence of contamination. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm distributed a notice to customers dated 07/06/2020 via email stating that lots 1029, 1029A, and 1029B need to be quarantined pending further investigation. Customers with questions are asked to contact Renee Schlick, Quality Assurance Manager, at 608-838-1640 or by email at rschlick@gentueri.com. |
| Quantity | 13,975 units (2 mL in a 15 mL conical tube) |
| Distribution | Domestic: Illinois, Nebraska, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.