Recall Z-0485-2019

Reason for recall

A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.

FDA-determined cause: Software design

Action taken

On September 28, 2018, the firm issued an Urgent Medical Device Recall letter to affected customers. Customers were informed of the software issue. The firm has released software version 2.51 (or later) which corrects the problem. Three analyzers were identified that do not have the most current software version and are at risk for the error: 10313605, 10503612, and 10634103. A field service engineer will be contacting customers with these units in their possession to schedule a service visit in order to upgrade those analyzers to the current version of the operating software. Immediate Actions to be taken by the Customer/User -Thoroughly review the content of this letter. -Complete and return the attached Acknowledgement Form. -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. 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).