Recall Z-3244-2018

Reason for recall

Analyzers were distributed with software which lacks a 510K

FDA-determined cause: No Marketing Application

Action taken

On July 13, 2018, Tosoh Bioscience started to telephone customers to set up on-site visits. On July 16, 2018, Tosoh Bioscience began to issue URGENT MEDICAL DEVICE RECALL notices to customers via hand delivery. Immediate Actions to be taken by the Customer/User: - Thoroughly review the content of this letter with the Tosoh field service representative. - Allow the Tosoh field representative to verify the software version currently on your analyzer - If the software is v5.23, your analyzer needs no further action - If the software is v5.24, allow the Tosoh field representative to download all patient results from your analyzer, remove software version v5.24, and upload software version v5.23. - Continue to use your analyzer and report results with software v5.23 once these activities have been completed. - Complete and return the Acknowledgement Form to the Tosoh field representative. - File the Urgent Medical Device Recall notice with your laboratory records and forward the information to others in your laboratory. If you have obtained unexpected test results 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 OConnell 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).