Recall Z-0475-2019

Reason for recall

There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.

FDA-determined cause: Component design/selection

Action taken

On September 28, 2018, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Tosoh has taken the required actions to inspect the liquid suction pump during preventative maintenance and correct the instruments where this issue has been observed. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. If additional information is needed, please contact Tosoh Technical Support. " Continue using your instrument. o If there is an unexplained rise in the calibration rate and the AIA-2000 Analyzer serial number is listed above, please contact Tosoh Technical Support. o If the assay calibration is as expected, then at the next scheduled Preventive Maintenance (PM) visit, a Tosoh field service engineer will inspect the liquid suction pump and replace it as needed. " File this notice with your laboratory records and forward this information to others in your laboratory. " Complete and return the attached Acknowledgement Form by any of the listed methods. If you have obtained unexpected test results, delays in test result reporting, or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).