Recall Z-1420-2020— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2020-01-10, terminated 2020-09-10. FDA's recall record names no specific 510(k) clearance for this event. Product: AIA-360 Automated Immunoassay Analyzer, Product Code 019945. 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
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-10
- Terminated
- 2020-09-10
- Firm location
- Grove City, OH, United States
Product description
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.