FDA DeviceClass IINotable
FDA Recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Description
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.
Hazard
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.
Remedy
7018 units
Related Recalls
2026-08-12 · FDA_DEVICE
FDA Recall: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Siemens Healthcare Diagnostics, Inc.
2026-08-12 · FDA_DEVICE
FDA Recall: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Siemens Healthcare Diagnostics, Inc.
2026-07-15 · FDA_DEVICE
FDA Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens Healthcare Diagnostics, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoass
Siemens Healthcare Diagnostics, Inc.