# FDA recall Z-1484-2026

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2026-01-20.

## Product

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

## Reason for recall

Falsely depressed UAlb patient  results may occur. Affected samples with any urine albumin concentration above the UAlb  measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

## Distribution

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

## Key facts

- **Recall number:** Z-1484-2026
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-20
- **Report date:** 2026-03-11

- **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-1484-2026

## Citation

> AI Analytics. FDA recall Z-1484-2026. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-1484-2026. Source: US FDA. Licensed CC0.

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