Recall Z-0387-2018 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Phadia US Inc
Phadia 1000 Instrument, Article Number 12-3800-01.
| Date | Jul 5, 2017 |
| Status | Terminated |
| Reason | The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. |
| Root cause | Device Design |
| Action | The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon. |
| Quantity | 70 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |