Siemens Dimension AST Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is inaccurate test results rather than direct physical injury or death.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959). The recall involves 181,072 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 with the drugs sulfasalazine and/or sulfapyridine. This interference may cause the assay to produce falsely elevated or falsely depressed results when measuring chemical levels in blood, urine, or cerebrospinal fluid.
Healthcare providers and laboratories should stop using the affected assays and contact Siemens Healthcare Diagnostics for further instructions on the recall.
The recalled product
- Product
- Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 181,072
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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