AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Reported: March 11, 2020 Initiated: January 10, 2020 #Z-1420-2020
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.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 12
- Distribution
- Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
AIA-360 Automated Immunoassay Analyzer, Product Code 019945. Recalled by Tosoh Bioscience Inc. Units affected: 12.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1420-2020.
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