Siemens Digoxin Reagent Cartridge Recalled for Incorrect Biotin Interference Labeling
Siemens Healthcare Diagnostics is recalling Dimension Vista Digoxin reagent cartridges because the instructions for use contain incorrect units and levels for biotin interference.
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, but the hazard is a labeling error regarding interference levels rather than a direct physical defect or reported injury, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 13,143 units of the Dimension Vista Digoxin (DIGXN) Flex reagent cartridge. The recall is due to an error in the Non-Interfering Substances section of the Instructions for Use (IFU). The IFU lists incorrect units and incorrectly states the level at which biotin does not interfere with the test results.
The affected product is the Dimension Vista Digoxin (DIGXN) Flex reagent cartridge, manufactured by Siemens Healthcare Diagnostics, Inc. The recall covers specific lots: 16103BD, 16195BB, 16230BA, 16259BD, 16320BD, and 16363BA. The device listing number is D098364.
The product was distributed throughout the United States, Canada, and numerous international locations including the United Arab Emirates, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Switzerland, China, Columbia, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, Finland, France, Great Britain, Greece, Croatia, Indonesia, Ireland, India, Italy, Japan, Canary Islands, Republic of Korea, Kuwait, Lebanon, Latvia, Macedonia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, Slovakia, Turkey, Taiwan, and South Africa. Users should check their inventory for the affected lot numbers and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 13,143
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 (6)
- Device Listing Number # D098364 Lot # 16103BD
- 16195BB
- 16230BA
- 16259BD
- 16320BD
- 16363BA
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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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