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.
What this means for you
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 seve
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- 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.
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