Siemens Healthcare recalls Atellica CH Fructosamine (Fruc) with material number 11097637 due to potential reagent carryover affecting patient test results. Affected units include specific lot numbers and UDI.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Siemens Healthcare is recalling Atellica CH Fructosamine (Fruc) devices because they might cause inaccurate test results due to reagent carryover. This could lead to incorrect patient samples and calibrator results if not addressed.
Reagent carryover can cause inaccurate test results, leading to incorrect patient samples and calibrator readings. This happens when residual reagent from previous tests contaminates new samples.
Laboratory users who own or use Atellica CH Fructosamine (Fruc) devices with Siemens Material Number 11097637 are affected. Those handling patient samples or calibrators are most at risk.
Check for Siemens Material Number 11097637 on the device. Affected units include lot numbers 211359 and 211451, and UDI 00630414595580.
Identify the Siemens Material Number 11097637 and lot numbers 211359 or 211451 to confirm if your device is affected.
The recall is for potential inaccurate test results, not direct patient harm. Siemens Healthcare confirms reagent carryover could affect quality control and patient samples.
Check for Siemens Material Number 11097637, lot numbers 211359 or 211451, and UDI 00630414595580 on the device.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0930-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0930-2022 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.
