Recall Z-2423-2020 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
| Date | May 22, 2020 |
| Status | Terminated |
| Reason | The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results. |
| Root cause | Component change control |
| Action | On May 22, 2020, the recalling firm distributed Urgent Medical Device Correction letters to affected customers. Customers were made aware of the product issue. Immediate Actions to be taken by the Customer/User " The affected AIA-900 Analyzers are listed above by serial number. Check the serial number of your analyzer to confirm that it has the affected substrate monitoring system. o If your analyzer is not listed, please complete the form and return it to Tosoh; no further action is required. o If your serial number is listed, a Tosoh service representative will contact you to arrange fo |
| Quantity | 529 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.