AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Recall
- Recall Number
- Z-2423-2020
- Event Number
- 85753
- Firm
- Tosoh Bioscience Inc
- FEI Number
- 3005529799
- Product Code
- KHO
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- May 22, 2020
- Terminated
- August 29, 2024
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895
Description
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
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.
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 for replacement of the LQC board. Additionally, please take the following actions. " Replace the Substrate bottle when the volume falls below 10 mL This is approximately inch from the bottom of the bottle or just below the bottom of the label. Be sure the supply tube extends to the bottom of bottle. Be sure to discard the substrate bottle with the remaining substrate; do not pool the remaining liquid into another bottle. " Prior to starting any run, check the volume of the substrate bottle to be sure there is enough substrate to complete the run. There are approximately 50 tests remaining in the bottle once the volume falls below the bottom edge of the label. A full bottle of substrate has approximately 500 tests. " If the substrate bottle runs dry or a DL Flag appears during a run, do not report the three (3) test results prior to the DL flag, these results may be erroneous. Replace the empty substrate bottle, repeat the Daily Check and re-run the three tests. " At the end of an assay run, check the volume of the substrate to ensure that there is fluid remaining in the bottle and the supply tube is properly submerged in the liquid. " File this notice with your laboratory records and forward this information to other supervisors or managers in your laboratory to ensure that they are aware of the potential issue. Should you have any questions regarding this m
Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.
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