AIA-360 Automated Immunoassay Analyzer, Product Code 019945

FDA device recall Z-1420-2020 · posted 2020-02-11 · Terminated

Recall details

Recalling firm

Tosoh Bioscience Inc

Reason for recall

A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

Action taken

The firm distributed Urgent Medical Device Correction letters to customers on January 10, 2020. Customers were instructed to retrain from touching the display panel while the analyzer is running. If the analyzer stops and/or the display freezes, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. If your analyzer's serial number is listed among the recalled units, you will be contacted by a Tosoh Field Service Engineer to schedule a visit to replace the display screen which will correct the potential issue. 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).

Root cause

Software design

Status

Terminated

Product code

KHO

Quantity affected

12

Distribution

Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay

Date initiated

2020-01-10

Date posted

2020-02-11

Date terminated

2020-09-10

Location

Grove City, OH