Siemens Healthcare Diagnostics, Inc. recalls Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes an…

Recall date

October 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0496-2025

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Congo, Republic C¿te dIvoire Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece H…

Why it was recalled

A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.