# FDA recall Z-1657-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2026-02-23.

## Product

Atellica CH Enzymatic Hemoglobin A1c (A1c_E);  Siemens Material Number (SMN): 11097536;

## Reason for recall

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.

## 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;

## Key facts

- **Recall number:** Z-1657-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-23
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1657-2026

## Citation

> AI Analytics. FDA recall Z-1657-2026. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1657-2026. Source: US FDA. Licensed CC0.

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