Recall Z-0559-2019

Reason for recall

The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.

FDA-determined cause: Labeling Change Control

Action taken

On August 23, 2018, the firm, Tosoh Bioscience, notified affected distributors and customers via "URGENT: MEDICAL DEVICE RECALL" letter. The described the product, problem and actions to be taken. Summary and location of labeling changes: - Elimination of monthly B/F probe maintenance. - Added requirement for use of 70% Ethanol. - Added requirement for use of CAP Class l reagent grade water per CLSI Guidelines and Standards. - Added clarification of substrate stability. Substrate, when stored at 2-8C between uses is stable for 30 days. Customers were asked to do the following: -Discontinue maintenance activities on the B/F probe. If issues with the B/F probe are observed, call Technical Support for assistance. - Please continue to perform all your other maintenance procedures at the required intervals as per the instructions in the Operators Manual. - Discard the Training DVD, it is now obsolete. An updated version of the Training DVD, QRG and Training Manual will be sent to you in a separate mailing. - At daily shutdown, use 70% Ethanol to replace the substrate solution. - Use only CAP Class l reagent grade water. - Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. - Maintain this notification with your laboratory records and forward this information to others who may have received this product. - If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of these products, 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 contact call (800) 248-6764 or email at bernadette.oconnell@tosoh.com Monday - Friday, from 9:00 AM to 5:00 PM (PST).