---
title: "Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): ... — FDA record Z-1657-2026 | Is It on Recall"
description: "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 a"
url: https://isitonrecall.com/recall/fda-device-z-1657-2026-atellica-ch-enzymatic-hemoglobin-a1c-a1c-e-siemens-material-number-smn-11097536/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Atellica CH Enzymatic Hemoglobin A1c (A1c\_E); Siemens Material Number (SMN): 11097536; — FDA record Z-1657-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 23, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Atellica CH Enzymatic Hemoglobin A1c (A1c\_E); Siemens Material Number (SMN): 11097536;
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Siemens Healthcare Diagnostics, Inc.
- **Quantity**: 21,291 units (9750 US, 11541 OUS)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1657-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1657-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity;

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## Dates in the source

- **Report date**: Apr 8, 2026
- **Recall initiation date**: Feb 23, 2026
- **Center classification date**: Mar 27, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1657-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Siemens Healthcare Diagnostics, Inc. records](https://isitonrecall.com/brand/siemens-healthcare-diagnostics-inc/)