Recall Z-2423-2020
Tosoh Bioscience Inc · initiated May 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Codes / lots: From customer letter: Serial numbers 10030810; 10101008; 10142204; 10212411; 10253902; 10263902 and higher serial numbers Complete list: (Distributed in US) 10030810 10050912 10071402 10101008 10142204 10162305 10202911 10212411 10222312 10253902 10263902 10273002 10303104 10303904 10313105 10313605 10333005 10333906 10343006 10343307 10353507 10353607 10353707R 10353807 10353907 10363507 10363608 10373108 10373408 10373508 10393108 10393208 10393308 10393908 10413009 10413509 10423409 10423909 10433009 10443110 10443210 10443310 10443710 10453310 10453410 10453810 10453910 10463010 10463110 10473111 10473211 10473311 10473411 10483411 10483511 10493111 10493411 10493711 10493911 10503011 10503111 10503211 10503311 10503612 10503912 10513412 10523912 10533012 10533112 10533212 10533412 10533612 10543012 10543212 10543412 10543512 10574301 10574601 10584702 10594502 10594602 10594702 10604902R 10614002 10614102 10614202 10614302 10624903 10634203 10634403 10634503 10644503 10644604 10644704 10644804 10644904 10654404 10654704 10654804 10654904 10664004 10664204 10674705 10674805 10684005 10684105 10684205R 10684405 10694406 10694606 10694706 10694806 10704006 10704807 10704907…
Reason for recall
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.
FDA-determined cause: Component change control
Action taken
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
Details
- Recall number
- Z-2423-2020
- Initiated
- May 22, 2020
- Terminated
- August 29, 2024
- Product code
- KHO – Fluorometer, For Clinical Use
- 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.
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH