Official recall notice

FDA DeviceClass IINotable

FDA Recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

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.

Product 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.

Affected products

All Lots within expiry/UDI: 00630414611099

Verify with the official notice →
Share:

Related Recalls

2026-08-26 · FDA_DEVICE
FDA Recall: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Siemens Healthcare Diagnostics, Inc.
2026-08-26 · FDA_DEVICE
FDA Recall: Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Siemens Healthcare Diagnostics, Inc.
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.