Siemens Healthcare recalls Atellica CH GGT test kits due to possible reagent carryover causing inaccurate results. Affected kits may lead to incorrect patient test outcomes. Contact for remedy details.
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 Gamma-Glutamyl Transferase (GGT) test kits because reagent carryover can cause positive bias in results. This may lead to inaccurate patient test outcomes, including quality control and calibrator results.
Reagent carryover during testing can cause positive bias in results. This may lead to inaccurate patient test outcomes, including quality control and calibrator results. The issue affects specific test kits for GGT, TBil_2, LDLC, and HDLC.
Lab technicians and healthcare providers using Siemens Atellica CH GGT test kits for patient testing. Those handling the specific kits with the listed lot numbers are most at risk.
Check for the Siemens Material Number (SMN): 11097597 or Unique Device Identification (UDI): 00630414596440 on the test kits. The kits are used for quantitative determination of gamma-glutamyl transferase in human serum and plasma.
Look for the Siemens Material Number (SMN): 11097597 or Unique Device Identification (UDI): 00630414596440 on the test kits.
The Atellica CH Gamma-Glutamyl Transferase (GGT) test kits with Siemens Material Number (SMN): 11097597 and Unique Device Identification (UDI): 00630414596440.
Reagent carryover during testing can cause positive bias in results, potentially leading to inaccurate patient test outcomes.
Check for the Siemens Material Number (SMN): 11097597 or Unique Device Identification (UDI): 00630414596440 on the test kits.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2473-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2473-2023 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.
