Siemens Dimension Troponin 1 Cartridge Recall for Incorrect Biotin Labeling
Siemens is recalling Dimension Troponin 1 reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.
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, but the source text identifies the issue as a labeling error in the Instructions for Use regarding biotin interference levels, which aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 70,428 units of the Dimension Troponin 1 (TNI) Flex reagent cartridge. The recall was initiated because the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) contains errors regarding biotin. Specifically, the IFU lists incorrect units and incorrectly states the level at which biotin does not interfere with the test results.
The affected product was distributed throughout the United States, Canada, and numerous other countries including those in Europe, Asia, the Middle East, and South America. The recall covers specific lot numbers: EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236, EA7250, ED7271, EB7315, and EB7342. The device listing number is D056469.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to Siemens Healthcare Diagnostics, Inc. according to the company's instructions. This recall addresses a documentation and labeling error in the instructions for use rather than a defect in the physical cartridge itself.
The recalled product
- Product
- Dimension Troponin 1 (TNI) Flex reagent cartridge
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 70,428
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 (11)
- Device Listing Number # D056469 Lot # EB7091
- EC7104
- EA7125
- ED7193
- EA7161
- EB7173
- EC7229
- ED7236 EA7250
- ED7271
- EB7315
- EB7342 "
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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