Recall Z-1939-2020 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Remel Inc.
SWIN 2017 database, Model YSW4000
| Date | Jan 4, 2019 |
| Status | Terminated |
| Reason | Potential for out of range microbial results |
| Root cause | Software design |
| Action | Technicians replaced YSW514-17 with YSW514-17A. |
| Quantity | 250 |
| Distribution | ... |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.