Siemens Healthcare recalls Atellica CH Urinary/Cerebrospinal Fluid Protein reagents that may cause falsely low hemoglobin A1c test results, affecting diabetes management decisions.
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) reagents that may produce falsely low hemoglobin A1c test results. This could lead to incorrect diabetes management decisions if the test results are used without knowing the reagent is faulty.
The reagent may cause hemoglobin A1c test results to be falsely low. This could lead to incorrect diabetes management decisions if the false low results are used to guide treatment.
People using Atellica CH UCFP reagents for hemoglobin A1c testing may be affected. Those with diabetes who rely on these test results for management decisions are at higher risk.
The affected reagents are labeled 'Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543'. All lots of this product are impacted.
Look for the lot number on the reagent packaging to confirm if it is affected.
The recall does not mention any risk of serious injury or harm. The potential issue is only with test results being falsely low.
Falsely low hemoglobin A1c results could lead to incorrect diabetes management decisions if the test results are used without knowing the reagent is faulty.
The recall does not specify a remedy. Check the lot number to see if it is affected, but no action is required if it is not impacted.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0180-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0180-2022 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.
