Siemens Healthcare recalls Advia UCFP reagents that may produce falsely low hemoglobin A1c results, affecting diabetes management decisions. Affected lots are identified by serial number.
The firm has confirmed the potential for ADVIA Chemistry 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 Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagents that could cause false low hemoglobin A:1c test results. This might lead to incorrect diabetes treatment decisions if the test results are used without correction.
The reagent may cause hemoglobin A1c tests to show falsely low results. This could lead to incorrect diabetes management decisions if healthcare providers rely on these results without adjustment.
People using the Advia UCFP reagents for hemoglobin A1c testing may be affected. Those with diabetes who rely on these test results for treatment decisions are at higher risk.
Check the serial number on the reagent vial. The affected product is labeled as Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) with serial number SMN 11319151.
Look for the serial number SMN 11319151 on the Advia UCFP reagent vial.
The reagent may cause hemoglobin A1c tests to show falsely low results, which could affect diabetes treatment decisions.
Check the serial number on the reagent vial. If it matches SMN 11319151, contact Siemens Healthcare for instructions.
No serious injury risk is described in the recall notice. The hazard is related to test results, not physical harm.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0181-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0181-2022 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.
