Siemens Dimension Ammonia Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.
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: This is an FDA Class II recall involving a potential for inaccurate test results due to drug interference, which fits the criteria for moderate severity as it poses a risk of misdiagnosis but does not involve immediate physical injury or death.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Ammonia (AMM) assay, Product Number DF119/10711991. The recall involves 37,923 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.
The recall is due to a potential interference issue where the assay may produce falsely elevated or falsely depressed results when used in the presence of the drugs sulfasalazine and/or sulfapyridine. This interference could affect the accuracy of chemical level measurements in blood, urine, or cerebrospinal fluid.
Healthcare facilities and laboratories that have received these products should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device used in clinical settings.
The recalled product
- Product
- Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 37,923
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 (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 17 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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