Siemens Healthcare recalls Atellica CH Fructosamine Reagent (FRUC) due to potential interference in blood glucose tests. Learn what to do if you have this reagent.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Siemens Healthcare is recalling Atellica CH Fructosamine Reagent (FRUC) because it may cause inaccurate blood glucose test results. This could lead to incorrect diabetes management decisions if used in patient testing.
The reagent contains NAPQI, a metabolite of acetaminophen, which can interfere with certain blood glucose tests. This interference may cause false results, potentially affecting diabetes management decisions.
Diabetic patients using this reagent for blood glucose monitoring may be at risk of inaccurate test results. Healthcare providers who use this reagent in clinical settings are also affected.
Check for Siemens Material Number 11097637 or UDI Number 00630414595580 on the reagent bottle. The reagent was sold in 2011 for use in blood glucose monitoring.
Look for Siemens Material Number 11097637 or UDI Number 00630414595580 on the reagent bottle.
The reagent may cause interference in blood glucose tests due to NAPQI, a metabolite of acetaminophen, which could lead to inaccurate diabetes management results.
Check the reagent bottle for Siemens Material Number 11097637 or UDI Number 00630414595580. If you have it, contact Siemens Healthcare for guidance.
The reagent may cause inaccurate test results, so it is recommended to stop using it if you have it and contact Siemens Healthcare for a replacement.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2281-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2281-2020 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.
