Siemens Healthcare recalls Atellica CH HDL Cholesterol test kits due to possible reagent carryover causing inaccurate lab results. Affected kits may lead to incorrect patient and quality control measurements.
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 HDL Cholesterol test kits because reagent carryover could cause inaccurate lab results. This might affect patient samples and quality control tests if not corrected.
Reagent carryover in the test kit can cause positive bias in results. This may lead to incorrect patient samples and quality control measurements if not addressed.
Lab users who test with Atellica CH HDL Cholesterol kits may be affected. Those handling patient samples or quality control tests are most at risk.
Check for the test code HDLC on the kit. The Siemens Material Number (SMN) is 11537213 and the Unique Device Identification (UDI) is 00630414610832. All lot numbers are affected.
Look for the test code HDLC, Siemens Material Number (SMN) 11537213, and Unique Device Identification (UDI) 00630414610832 on the kit.
Reagent carryover can cause positive bias in results, potentially affecting patient samples and quality control tests.
Check for test code HDLC, Siemens Material Number (SMN) 11537213, and Unique Device Identification (UDI) 00630414610832 on the kit.
The recall record does not specify a remedy, so no action is required beyond checking if you have the kit.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2474-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2474-2023 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.
