Tosoh AIA-900 immunoassay Analyzer recall: Software Issue
Tosoh AIA-900 immunoassay Analyzer
Why was Tosoh AIA-900 immunoassay Analyzer recalled?
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
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?
10313605 10503612 10634103
- Product
- Tosoh AIA-900 immunoassay Analyzer
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 3
- Distribution
- Distributed to accounts in GA and NY.
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)