Siemens Healthcare recalls Atellica CH Lithium_2 (LITH_2) devices with specific lot numbers due to potential reagent carryover affecting test accuracy. Affected units may cause incorrect patient results.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Siemens Healthcare is recalling Atellica CH Lithium_2 (LITH_2) devices with certain lot numbers because they might cause inaccurate test results. This could lead to incorrect patient diagnoses or treatment decisions if the device is used without the recall fix.
The devices may have reagent carryover that affects quality control tests, patient samples, and calibrator results. This can lead to incorrect test outcomes, potentially causing wrong diagnoses or treatment decisions.
Users of Atellica CH Lithium_2 devices with lot numbers 110108, 110185, 110238, or 110302 are affected. Laboratory staff and healthcare providers who use these devices for patient testing are most at risk of inaccurate results.
Check the lot number on your Atellica CH Lithium_2 device. Lot numbers 110108, 110185, 110238, and 110302 are affected. The device has a unique identifier (UDI) starting with 00630414287935.
Look for the lot number on your Atellica CH Lithium_2 device. Affected units have lot numbers 110108, 110185, 110238, or 110302.
The device may cause inaccurate test results, potentially leading to incorrect patient diagnoses or treatment decisions.
Check the lot number on your Atellica CH Lithium_2 device. Affected units have lot numbers 110108, 110185, 110238, or 110302.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0931-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0931-2022 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.
