Siemens Creatine Kinase MB Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it 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. The hazard involves potential diagnostic errors due to drug interference, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate severity criteria for labeling or performance issues without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510). The recall involves 30,446 units distributed in all 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and 108 foreign countries.
The recall was initiated because the assay may interfere with the drugs sulfasalazine and/or sulfapyridine. This interference can cause falsely elevated or falsely depressed results when measuring chemical levels in blood, urine, or cerebrospinal fluid.
Healthcare providers and facilities using this assay should stop using the affected product and contact Siemens Healthcare Diagnostics for further instructions. Consumers should not use this product at home, as it is a medical device intended for professional use.
The recalled product
- Product
- Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 30,446
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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