Siemens Dimension Vista Glucose Assay Recalled for Drug Interference
Siemens is recalling Dimension Vista Glucose 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: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors due to drug interference, which is a significant risk but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 19,245 units of the Dimension Vista Glucose (GLU) assay (Product Number: K1039/10445162). The recall covers all lots of the product.
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 glucose results.
The affected products were 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 assays and contact Siemens for instructions on how to proceed.
The recalled product
- Product
- Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 19,245
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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