Siemens Healthcare recalls Atellica CH Ethyl Alcohol test kits with potential positive bias in patient results and QC tests within 10-day calibration intervals. Affected lots include 190133, 190222, 100066, 100168.
The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
Siemens Healthcare is recalling Atellica CH Ethyl Alcohol test kits that may show falsely high alcohol levels in patient results and quality control tests. This could lead to incorrect diagnoses if the test is used within the 10-day calibration window.
The test may show a positive bias, meaning it could indicate higher alcohol levels than actually present. This risk occurs within the 10-day calibration period after the test kit is manufactured and used.
Users of Atellica CH Ethyl Alcohol test kits for alcohol testing are affected. Those using the test kits within the 10-day calibration interval are most at risk of inaccurate results.
Check the lot number on the test kit label. Affected lots include 190133, 190222, 100066, and 100168. The product is sold as an ethyl alcohol assay for in vitro diagnostic use.
Look for the lot number on the test kit label to determine if it is affected (190133, 190222, 100066, or 100168).
The test may show a positive bias, meaning it could indicate higher alcohol levels than actually present in patient results and quality control tests within the 10-day calibration interval.
Affected lots include 190133, 190222, 100066, and 100168.
Check the lot number on the test kit label. If it matches 190133, 190222, 100066, or 100168, it is affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1599-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1599-2020 from Siemens Healthcare. 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.
