Siemens Creatine Kinase MB Assay Recalled for Drug Interference
Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it 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: The recall is classified as FDA Class II, and the hazard involves potential diagnostic inaccuracy due to drug interference rather than direct physical injury or high-risk pathogen exposure.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista Creatine Kinase MB (MBI) assay, Product Number K3032/10464339. The recall involves 3,130 units of the product.
The recall was initiated because the assay may interfere with the drugs sulfasalazine and/or sulfapyridine, potentially causing falsely elevated or falsely depressed results. This interference could affect the accuracy of chemical level measurements in blood, urine, or cerebrospinal fluid.
The affected product was distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico, as well as in 108 foreign countries. Healthcare facilities and laboratories should stop using the affected lots and contact Siemens for further instructions.
The recalled product
- Product
- Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,130
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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