Siemens Healthcare Diagnostics is recalling 4,885 units of its Atellica CH Urine Albumin (UAlb) test kits due to a defect that can cause falsely low patient results. Affected samples with high albumin concentrations above 40.0 mg/dL may incorrectly report much lower values between 6.2 mg/dL and 40.0 mg/dL. This recall affects all lot numbers of material number 11537225 distributed worldwide between January and March 2026. Lab supervisors and healthcare providers should stop using the affected test kits and contact the manufacturer for correction or replacement.
The device may report falsely low urine albumin levels for patients who actually have high concentrations, potentially leading to the misdiagnosis or delayed treatment of kidney disease or other medical conditions. No specific injuries have been reported in the data, but inaccurate diagnostic results pose a moderate risk to patient safety.
Falsely depressed results may occur for samples above the measuring interval.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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