Recall Z-0485-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
Tosoh AIA-900 immunoassay Analyzer
| Date | Sep 28, 2018 |
| Status | Terminated |
| Reason | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result. |
| Root cause | Software design |
| Action | On September 28, 2018, the firm issued an Urgent Medical Device Recall letter to affected customers. Customers were informed of the software issue. The firm has released software version 2.51 (or later) which corrects the problem. Three analyzers were identified that do not have the most current software version and are at risk for the error: 10313605, 10503612, and 10634103. A field service engineer will be contacting customers with these units in their possession to schedule a service visit in order to upgrade those analyzers to the current version of the operating software. Immediate Acti |
| Quantity | 3 |
| Distribution | Distributed to accounts in GA and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.