AIA-360 Automated Immunoassay Analyzer recall: Software Issue
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Why was AIA-360 Automated Immunoassay Analyzer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
28469102 28629205 28469202 28629305 28469302 28629405 28469402 28629505 28469502 28629605 28469602 28629705 28469702 28709907 28469802 28719007 28469902 28719107 28479002 28719207 28519303 28719307 28519403 28719407 28519503 28719507 28519603 28719607 28519703 28719707 28519803 28719807 28519903 28719907 28529003 28729007 28529103 28729108 28529203 28729208 28529903 28729308 28539003 28729408 28539103 28729508 28539203 28729608 28539303 28759908 28539403 28769008 28539503 28769108 28539603 28769208 28539703 28769308 28539803 28769408
- Product
- AIA-360 Automated Immunoassay Analyzer, Product Code 019945
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 12
- Distribution
- Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)