Recall Z-1420-2020 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
| Date | Feb 11, 2020 (initiated Jan 10, 2020) |
| Status | Terminated |
| Reason | A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable. |
| Root cause | Software design |
| Action | The firm distributed Urgent Medical Device Correction letters to customers on January 10, 2020. Customers were instructed to retrain from touching the display panel while the analyzer is running. If the analyzer stops and/or the display freezes, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. If your analyzer's serial number is listed among the recalled units, you will be contacted by a Tosoh Field Service Engineer to schedule a visit to replace the display screen which will correct the potential issue. Should you have any questions regarding this m |
| Quantity | 12 |
| Distribution | Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.