Recall Z-0559-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
| Date | Aug 23, 2018 |
| Status | Terminated |
| Reason | The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP |
| Root cause | Labeling Change Control |
| Action | On August 23, 2018, the firm, Tosoh Bioscience, notified affected distributors and customers via "URGENT: MEDICAL DEVICE RECALL" letter. The described the product, problem and actions to be taken. Summary and location of labeling changes: - Elimination of monthly B/F probe maintenance. - Added requirement for use of 70% Ethanol. - Added requirement for use of CAP Class l reagent grade water per CLSI Guidelines and Standards. - Added clarification of substrate stability. Substrate, when stored at 2-8C between uses is stable for 30 days. Customers were asked to do the following: -Discontinue |
| Quantity | 1228 |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.