Siemens Recalls Dimension TSHL Reagent Cartridges Due to Biotin Labeling Error
Siemens Healthcare Diagnostics is recalling Dimension TSHL reagent cartridges because the instructions for use incorrectly state the biotin concentration level at which interference does not occur.
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 Moderate because it involves a minor labeling error regarding interference levels, with no reported injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridges. The recall is due to an error in the instructions for use (IFU) regarding the concentrations of biotin listed in the non-interfering substances section.
The IFU incorrectly states the level at which biotin does not interfere with the test results. This labeling error affects the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS products. The affected lot codes are EB7276, EC7298, EA7318, EB7346, EC7346, EA8012, EA8033, EA8051, EC8080, EB8107, EB8121, EA8143, EB8143, EA8177, EB8177, EB8199, EA8223, EA8241, and EA8261.
The product was distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. Users should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- Dimension¿ Thyroid Stimulating Hormone (TSHL) 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)
- TSHL
- radioimmunoassay
- thyroid-stimulating hormone
- RF612
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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