Siemens Healthcare recalls Atellica CH Total Bilirubin_2 test kits due to possible reagent carryover causing inaccurate lab results. Affected units may lead to incorrect patient diagnoses.
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿CH HDL Cholesterol (HDLC)
Siemens Healthcare is recalling Atellica CH Total Bilirubin_2 test kits because reagent carryover can cause inaccurate lab results. This could lead to incorrect patient diagnoses if used in quality control checks.
Reagent carryover during testing can cause positive bias in results, leading to inaccurate quality control checks. This may affect patient samples and calibrator results, potentially causing incorrect diagnoses.
Lab technicians and healthcare facilities using Siemens Atellica CH Total Bilirubin_2 test kits for bilirubin testing. Those handling the test kits for patient samples are most at risk.
Check for the test code TBil_2 on the kit. The Siemens Material Number (SMN) is 11097531 and the Unique Device Identification (UDI) is 00630414595818. All lot numbers are affected.
Verify the test code TBil_2, Siemens Material Number (SMN) 11097531, and Unique Device Identification (UDI) 00630414595818 on the kit.
Reagent carryover can cause positive bias in results, leading to inaccurate quality control checks and potentially incorrect patient diagnoses.
Check for test code TBil_2, Siemens Material Number (SMN) 11097531, and Unique Device Identification (UDI) 00630414595818 on the kit.
No action is required beyond checking the kit details. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2471-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2471-2023 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.
