# FDA recall Z-2890-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2026-07-06.

## Product

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

## Reason for recall

Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

## Distribution

Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿

## Key facts

- **Recall number:** Z-2890-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-06
- **Report date:** 2026-08-12

- **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-2890-2026

## Citation

> AI Analytics. FDA recall Z-2890-2026. Retrieved 2026-09-02 from https://api.ai-analytics.org/recall/Z-2890-2026. Source: US FDA. Licensed CC0.

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