Siemens TSH Reagent Cartridge Recall for Rare Variant Detection Failure
Siemens Healthcare Diagnostics is recalling Dimension Vista System TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.
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. The hazard involves a diagnostic limitation regarding a rare variant without reported injuries or deaths, fitting the criteria for a moderate severity recall involving potential adverse health consequences through misdiagnosis.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). The product is intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). The recall involves 18,584 units.
The recall was initiated because a rare variant of TSH, identified in a small cluster of patients, is not detected by the cartridge. This limitation may result in inaccurate test results for patients with this specific variant.
The affected units were distributed worldwide, including the United States (nationwide) and numerous international countries. Consumers and healthcare providers should contact Siemens Healthcare Diagnostics, Inc. for further instructions regarding the recall and replacement of the affected cartridges.
The recalled product
- Product
- Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 18,584
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 (1)
- Per recall strategy.
Distribution
Distributed nationwide across the United States.
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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