Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1140-2017·Announced 2017-02-15

Siemens Dimension Ammonia Reagent Cartridges Recalled for Calibration Issues

Siemens Healthcare Diagnostics is recalling specific lots of Dimension Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially leading to abnormal assay results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to potential assay errors (reagent instability) rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 11,165 units of Dimension Ammonia Flex reagent cartridges (AMM method) under recall number Z-1140-2017. The affected lots are EB7180, FB7152, BA7194, EA7223, and BA7250. These products are in vitro diagnostic tests used for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system.

The recall was initiated because the identified lots do not meet the 60-day calibration interval claim due to reagent instability. This instability may cause the system to display an "Abnormal Assay" result. The agency has classified this as a Class II recall.

The affected products were distributed nationwide in the United States and internationally to numerous countries including Argentina, Austria, Australia, Canada, China, France, Germany, and Japan. Users of these reagent cartridges should check their inventory for the specific lot numbers listed and contact Siemens Healthcare Diagnostics for further instructions or replacement.

The recalled product

Product: Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: reagent-instability
assay-error
Affected units: 11,165

Is your product affected?

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

Lot numbers (5)

lots EB7180
FB7152
BA7194
EA7223
BA7250

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

See all →

High
Siemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
Severe
Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
Severe
Siemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
High
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
Low
Syva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12

Same hazard · reagent instability