Company: Tosoh Bioscience Inc
Date of Enforcement Report: 3/11/2020
Class II
PRODUCT
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
- Recall Number: Z-1420-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Tosoh Bioscience Inc on 1/10/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12
DISTRIBUTION
US Nationwide and International