Siemens Recalls Dimension Vista TSH Reagent Cartridges for Labeling Error
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.
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 involves a minor labeling error regarding biotin interference levels, which fits the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Thyroid Stimulating Hormone (TSH) 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 results.
The affected product is distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The recall includes specific lot codes: 16277BD, 16322BB, 17005BB, 17023AC, 17069AA, 17093BB, 17122AA, 17150AA, 17193BA, 17215AC, and 17268AA.
Healthcare providers and laboratories should stop using the affected cartridges and contact Siemens Healthcare Diagnostics for further instructions on how to return or replace the product.
The recalled product
- Product
- Dimension Vista¿ Thyroid Stimulating Hormone (TSH) 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)
- TSH
- 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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