Recall Z-0601-2019

Reason for recall

Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.

FDA-determined cause: Device Design

Action taken

The firm sent notification to consignees on October 5, 2018, via Urgent Medical Device Recall letter. The letter informed consignees of the potential degradation of HbA1c control lot 7055 prior to the 60-days product stability claim. Immediate Actions to be taken by the Customer " Review the content of this letter with your laboratory staff. " Inform laboratory staff to avoid storing the control material in direct exposure to light. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. " In the event of an early degradation of the control material, new controls should be used to verify the instrument performance prior to use. " Maintain this notification with your laboratory records and forward this information to others in your laboratory. " 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).