Siemens Atellica CH Urine Albumin Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics is recalling 7,018 units of Atellica CH Urine Albumin REF 11537225 due to processing issues on CI analyzers that may cause falsely depressed results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Siemens Healthcare Diagnostics, Inc. initiated a voluntary recall of the Atellica CH Urine Albumin assay because processing on CI analyzers may lead to falsely depressed Atellica CH Urea Nitrogen (UN_c) results, falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results, increased reaction cuvette QC failures, and delayed results.
Which Products Are Affected
The recall covers Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic device. All lots within expiry are affected under UDI 00630414611099. A total of 7,018 units are involved. Distribution was worldwide, including the United States nationwide, Puerto Rico, and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, 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, and United Kingdom.
What You Should Do
Users should contact the recalling firm, Siemens Healthcare Diagnostics, Inc., at 511 Benedict Ave, Tarrytown, NY 10591-5005, for additional information regarding the recall.
Why This Matters
This Class II recall involves an in vitro diagnostic device distributed globally that may produce inaccurate laboratory results for urea nitrogen and hemoglobin A1c testing.
Source
FDA recall number Z-2890-2026, event ID 99389.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,479 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.