Recall Z-0469-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-900 Analyzer, Product code 022930, 022930R
| Date | Oct 5, 2018 |
| Status | Terminated |
| Reason | Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported. |
| Root cause | Device Design |
| Action | On October 5, 2018, the firm notified its affected customers via an Urgent Medical Device Recall letter. The letter informed customers of the potential product issue with all active AIA-900 analyzers. The firm's service procedures have been updated to proactively troubleshoot and correct the pickup arm and pickup arm motor during installations and scheduled preventive maintenance visits. At the next scheduled preventive maintenance visit a Tosoh field service engineer will verify the pickup arm motor current and adjust as needed. Adherence to preventive maintenance schedules provides effectiv |
| Quantity | 393 |
| Distribution | Distributed nationwide. Foreign distribution to Canada and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.