Siemens IMMULITE TSH Assay Recalled for Rare Variant Detection Failure
Siemens Healthcare Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical diagnostic device) where the failure to detect a rare TSH variant could lead to misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE Systems Third Generation TSH assays (REF LKTS1, LKTS5, L2KTS2, L2KTS6). These medical devices are intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). The recall involves 51,792 units distributed nationwide in the United States and in numerous countries worldwide, including Canada, Australia, and various nations in Europe, Asia, and the Americas.
The recall is being conducted because a rare variant of TSH, identified in a small cluster of patients, is not detected by the assay. This limitation may affect the accuracy of TSH measurements for patients with this specific variant.
Healthcare providers and laboratories should stop using the affected IMMULITE Systems Third Generation TSH assays. Siemens Healthcare Diagnostics, Inc. is the recalling firm and is managing the recall strategy.
The recalled product
- Product
- IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 51,792
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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