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

Source: FDA · Worldwide

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Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin kits because they may provide falsely low results for patients with high albumin concentrations.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin kits because they may provide falsely low results for patients with high albumin concentrations.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.