Siemens Healthcare recalls Atellica CH LDL Cholesterol test kits due to risk of false positive results affecting patient samples and quality control. Affected units may have reagent carryover causing inaccurate cholesterol readings.
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 LDL Cholesterol test kits because reagent carryover can cause false positive results in patient samples and quality control tests. This could lead to inaccurate cholesterol readings and potential misdiagnosis.
The test kit may have reagent carryover that causes false positive results. This can affect quality control, patient samples, and calibrator results for LDL cholesterol, total bilirubin, gamma-glutamyl transferase, and HDL cholesterol tests.
Lab users and healthcare professionals who perform cholesterol tests with the Atellica CH LDL Cholesterol kit. Those most at risk are individuals relying on accurate cholesterol results for medical decisions.
The Atellica CH LDL Cholesterol test kit (Test Code: LDLC) with Siemens Material Number 11537214 or Unique Device Identification 00630414611037. All lot numbers are affected.
Verify the test kit's Siemens Material Number (11537214) or Unique Device Identification (00630414611037) to confirm it is affected.
The test kits may have reagent carryover causing false positive results in patient samples and quality control tests for LDL cholesterol, total bilirubin, gamma-glutamyl transferase, and HDL cholesterol.
Check for Siemens Material Number 11537214 or Unique Device Identification 00630414611037 on the kit. All lot numbers are affected.
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-2472-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2472-2023 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.
