Recall Z-1183-2018 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Quidel Corporation
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
| Date | Dec 15, 2017 |
| Status | Terminated |
| Reason | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Quidel sent and Urgent Product Recall letter dated December 15, 2017. The letter instructs the user to discontinue use of the device until new firmware can be installed. For further questions, please call (800) 874-1517. |
| Quantity | 482 units |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |