Siemens Healthcare Diagnostics Recalls Atellica CH Urine Albumin Test Kits Due to Inaccurate Results

What Happened

Siemens Healthcare Diagnostics, Inc. has initiated a voluntary recall of its Atellica CH Urine Albumin (UAlb) diagnostic test kits. The recall was issued because the product may produce falsely depressed patient results. According to the FDA, samples with a urine albumin concentration above the measuring interval (>40.0 mg/dL) may incorrectly report values between 6.2 mg/dL and 40.0 mg/dL.

Which Products Are Affected

The recall involves approximately 4,885 units distributed worldwide, including across the United States. The following product details identify the affected items:

• Product Name: Atellica CH Urine Albumin (UAlb)
• Material Number: 11537225
• UDI-DI: 00630414611099
• Lot Numbers: All lot numbers are included in this recall.

What You Should Do

Siemens Healthcare Diagnostics notified customers of this issue via a formal letter. Laboratories and healthcare facilities using the Atellica CH Urine Albumin kits should follow the instructions provided in the firm’s notification. This typically includes identifying affected inventory and assessing the need for potential re-testing of patient samples that may have been impacted by the reporting error.

Why This Matters

Inaccurate medical test results can lead to incorrect clinical assessments and delayed treatment for patients. Falsely low albumin readings may mask underlying medical conditions that require intervention.

Source

This information is based on official recall data from the FDA under recall number Z-1484-2026.