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Class II Medical Device Z-2890-2026 Ongoing

Not the test being run, but the one beside it — a urine albumin assay depressing other results

Siemens Healthcare Diagnostics, Inc. ・Reported Aug 12, 2026

Siemens Healthcare Diagnostics reported that running its urine albumin assay on CI analyzers can depress urea nitrogen and enzymatic hemoglobin A1c results, raise the rate of quality control failures, and delay results.

Recall overview (primary data)

  • ClassificationClass II
  • Product typeMedical Device
  • Recalling firmSiemens Healthcare Diagnostics, Inc.
  • ReasonProcessing 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.
  • DistributionWorldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, Franc...
  • Recall initiated2026-07-06

Key points

  • The product is Atellica CH Urine Albumin, reference 11537225, an in vitro diagnostic.
  • Processing the urine albumin assay on CI analyzers may leave Atellica CH urea nitrogen results falsely depressed.
  • Enzymatic hemoglobin A1c results on the same system may likewise come out falsely depressed.
  • The rate of reaction cuvette quality control failures may rise, with results delayed as a consequence.
  • The recalling firm is Siemens Healthcare Diagnostics, Inc., the quantity 7,018 units, distributed across the United States and 34 further countries and territories.

1What breaks is not the test being run

When a diagnostic instrument goes wrong, the natural expectation is that the results of that test become doubtful. Not so here. Running the urine albumin assay disturbs the results of other tests processed on the same instrument.

2Where the effect lands

The aspectThe test being measuredThe tests affected
WhichUrine albuminUrea nitrogen and enzymatic hemoglobin A1c
How they go wrong—Results come out falsely depressed
What that means clinically—Markers of kidney function and of long-term glucose control look better than they are
Further effects—A higher rate of reaction cuvette quality control failures, and delayed results

The direction matters: falsely depressed. Urea nitrogen speaks to kidney function and hemoglobin A1c to glucose control over months. In both, a low figure reads as good. Looking better than the truth is what delays the response that should have followed.

3Tests on one instrument are not independent

Of the 1,408 records this site holds as of 2026-09-05, those without an article1,315Devices account for 744 (56.6%)
Quantity in this recall7,018 unitsDistributed across the United States and 34 further countries and territories
Devices classed as in vitro diagnostics29Within those 744 device records

Clinical laboratories now run many assays on one instrument, through shared reagent handling and a shared reaction system. A reagent introduced for one test can bear on the reaction of another. This record is a case of that interaction actually occurring.

4How it shows itself

  1. 1What happensThe urine albumin assay is processed on a CI analyzer
  2. 2The first effectUrea nitrogen and hemoglobin A1c results come out falsely depressed
  3. 3The second effectThe rate of reaction cuvette quality control failures rises
  4. 4What followsResults are delayed because of those failures

The mention of rising quality control failures matters. The instrument is catching an abnormality on its own. Results come out falsely low while the instrument's own checks register that something is wrong, and the record sets both symptoms of one cause side by side.

Why it matters

Tests sharing one analyzer are not independent of one another: a reagent introduced for one assay can bear on the reaction of another, so a fault reaches past the test being run. Where the direction is toward falsely depressed values, markers of kidney function and glucose control look better than they are and the response they should prompt is delayed. That quality control failures rise at the same time shows the instrument registering the fault on its own.

FAQ

Why are tests other than the one being run affected?
Because one instrument processes many assays through a shared reaction system. The record states that processing the urine albumin assay may bear on other results.
Why does falsely depressed matter?
Both urea nitrogen and hemoglobin A1c read as better when lower, so a depressed result can look reassuring and delay a response that was needed.
Does the instrument detect anything?
The record states that the rate of reaction cuvette quality control failures rises, and that results are delayed as a result.

Related explainers

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA recalls#In vitro diagnostics#Laboratory testing#United States#Product safety

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