Siemens Dimension Free Thyroxine Reagent Cartridge Recall for Labeling Error
Siemens is recalling Dimension Free Thyroxine reagent cartridges because the instructions for use incorrectly state the level at which biotin does not interfere.
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 source text describes a labeling error regarding interference levels without reporting any illnesses or injuries, fitting the criteria for a moderate severity recall involving minor labeling errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Free Thyroxine (FT4L) Flex reagent cartridges. The recall is due to an error in the instructions for use, which incorrectly state the level at which biotin does not interfere with the test.
The affected product is the Dimension Free Thyroxine (FT4L) Flex reagent cartridge. The source text notes that similar labeling errors regarding biotin interference levels exist in the instructions for use for other Siemens products, including Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS. The recall covers products distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand.
Specific lot codes affected by this recall include EA7276, EC7304, EC7333, EA7346, EB8010, EA8037, EA8065, EB8086, EB8108, EA8130, EA8156, EA8179, EA8205, EA8233, and FD8254. The source text does not specify a quantity of units recalled or report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (4)
- FT4L
- radioimmunoassay
- free thyroxime
- RF610
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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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