Arkray recalls AUTION AU-4050 lab equipment due to software error that could assign incorrect patient results under rare conditions. No remedy specified in official notice.
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
Arkray is recalling its AUTION AU-4050 lab equipment because a software issue could lead to incorrect patient results if three specific rare events happen together. This affects lab users who might get wrong test results.
The software error could assign wrong patient information to test results if three specific rare conditions occur: no urine sediment measurements generate results, the instrument shuts down incorrectly, and an item rack is used for new samples. This is extremely unlikely but could cause misdiagnosis.
Lab users with the AUTION AU-4050 equipment are affected. Those handling samples in clinical settings face the highest risk due to potential incorrect patient results.
The AUTION AU-4050 lab equipment with any serial number is affected. No specific model or purchase date is mentioned in the recall notice.
Verify if you own the AUTION AU-4050 lab equipment with any serial number.
The official recall notice does not specify any remedy for this issue.
The software error could assign incorrect patient information to test results if three specific rare conditions happen together: no urine sediment measurements generate results, the instrument shuts down incorrectly, and an item rack is used for new samples.
The AUTION AU-4050 lab equipment with any serial number is affected. No specific model or purchase date is mentioned in the recall notice.
We’ve drafted a message you can send Arkr: AUTION to request your refund or repair — edit it as you like.
Subject: Recall Z-1850-2019 — Arkr: AUTION Arkr: AUTION Hello, I own a Arkr: AUTION that is covered by recall Z-1850-2019 from Arkr: AUTION. 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.
