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Medical Device

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Recall date: 2026-08-12 · Source: FDA_DEVICE
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Reason for recall
Processing 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.
Units affected
7018 units
Description
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
View official recall notice →