Siemens Dimension Vista LOCI TSH Test Recalled for Inaccurate Results
Siemens is recalling 2,256 units of the Dimension Vista LOCI TSH test due to a defect that may cause falsely low results.
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, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes a defect causing inaccurate test results but does not report any specific injuries, illnesses, or hospitalizations, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,256 units of the Dimension Vista Systems LOCI Thyroid Stimulating Hormone (TSH) test. The affected product is identified by Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, and an expiration date of August 25, 2015. The product was distributed nationwide and to several international countries, including Australia, Japan, New Zealand, Canada, and various European nations.
The recall was initiated because the TSH test may produce falsely depressed results ranging from -23% to -96% near the end of the well set. This inaccuracy is attributed to inadequate reagent volume in a Flex well. The test is an in vitro diagnostic used for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma.
Healthcare facilities and laboratories that have received this specific lot should stop using the product and contact Siemens Healthcare Diagnostics, Inc. for instructions on return or replacement. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 2,256
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)
- Catalog Number K6412
- Material Number 10445104
- Lot Number 14237AA
- exp. 2015-08-25.
Distribution
Distributed nationwide across the United States.
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