Siemens Healthcare Diagnostics has recalled 38,128 units of Atellica CH and ADVIA Chemistry Microalbumin_2 diagnostic test kits used for measuring microalbumin in human urine. These tests are failing to correctly identify extremely high protein levels, which can cause the analyzers to report a falsely low result instead of a high one. This issue affects several laboratory systems including Atellica CH, Atellica CI, and multiple ADVIA Chemistry models.
A falsely low test result may lead a healthcare provider to believe a patient has normal or slightly elevated protein levels when they actually have severe albuminuria. This could result in a delayed diagnosis or incorrect management of kidney disease or other serious metabolic conditions.
Manufacturer notification via letter
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.
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Sources: FDA iRES · Raw API Response
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