Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy

Plain-English summary

Siemens Healthcare Diagnostics is recalling approximately 9,729 Atellica CH Reaction Ring Cuvette Segments (Siemens Material Number 11099326) due to a manufacturing defect. The cuvettes are components used in laboratory analyzers to contain and incubate sample reactions.

A manufacturing defect causes these cuvettes to produce inaccurate test results. The devices can output erroneously depressed or elevated results for seven analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate. Inaccurate test results could impact patient diagnosis and clinical decision-making.

The recall applies to all Atellica CH Reaction Ring Cuvette Segments with lot numbers beginning with "N15" on the packaging or "15" on the underside of the segment. These units have been distributed nationwide throughout the United States and internationally.

The recalled product

Product

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.

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Category

Medical Device — Laboratory Analyzer Component

Hazard

• test-inaccuracy
• manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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