Recall Z-0613-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
| Date | Mar 22, 2017 |
| Status | Terminated |
| Reason | The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received three (3) complaints related to this issue with no serious injuries reported. |
| Root cause | Process control |
| Action | On October 5, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. Customers were informed of the potential issue with the analyzer that could prevent the table home sensor from detecting the table home position. Customers were advised that the table home sensor board will be evaluated and replaced if needed at the next scheduled preventive maintenance visit. Actions to be taken by User: " Thoroughly review the content of this letter. " Continue to use your analyzer. A Tosoh representative will contact you to schedule your next preventive maintenance visit |
| Quantity | 438 |
| Distribution | Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.