Siemens recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E) test kits that may produce lower than actual results when used with certain analyzers, potentially delaying diabetes diagnosis.
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c (A1c_E) test kits that may give falsely low results when processed on the same analyzer as Atellica CH RCRP. This could delay diabetes diagnosis or lead to inadequate treatment for existing diabetes cases.
The test kits may produce lower than actual results when processed on the same analyzer as Atellica CH RCRP. This issue worsens over time and causes inconsistent results that can affect diabetes diagnosis and treatment.
Lab users who process Atellica CH A1c_E and Atellica CH RCRP on the same analyzer are affected. Patients with diabetes are at risk of delayed diagnosis or suboptimal treatment.
Check for Siemens Material Number (SMN) 11097536 on the test kits. Lot numbers include 150131 through 150621. The test kits are sold by Siemens Healthcare Diagnostics.
Look for lot numbers 150131 through 150621 on the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) test kits.
The test kits may produce lower than actual results when processed on the same analyzer as Atellica CH RCRP, which could delay diabetes diagnosis or lead to inadequate treatment.
No, but you should check if your test kits have the affected lot numbers and avoid using them with Atellica CH RCRP on the same analyzer.
Check the lot numbers on your test kits. If they match the affected range, you should not use them with Atellica CH RCRP on the same analyzer.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1657-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1657-2026 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.
