Tosoh recalls AIA-900 immunoassay analyzers due to software issue causing potential test delays. Affected units may need software update to prevent inaccurate results.
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.
Tosoh is recalling its AIA-900 immunoassay analyzers because a software problem might cause test delays by overwriting reagent bottle data. This issue is fixed with a software update but doesn't pose serious injury risks.
The software issue causes the analyzer to overwrite data from the second and third reagent bottles with the first bottle's information. This leads to slight delays in testing patient samples or reporting results, but does not cause injuries or equipment damage.
Healthcare facilities using Tosoh AIA-900 analyzers with serial numbers 10313605, 10503612, or 10634103 are affected. Laboratory staff and technicians handling these devices are most at risk.
Check your Tosoh AIA-900 analyzer's serial number against 10313605, 10503612, or 10634103. The device is sold as an immunoassay analyzer for medical testing.
Install software version 2.51 or later to fix the data overwrite issue.
No, the recall only causes potential test delays, not injuries or equipment damage.
Check your serial number against 10313605, 10503612, or 10634103.
Install software version 2.51 or later to resolve the issue. No immediate action is needed beyond the update.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-0485-2019 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-0485-2019 from Tosoh. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
