Siemens IMMULITE Rapid TSH Recalled for Rare TSH Variant Detection Failure
Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.
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. The hazard involves a risk of harm (inaccurate diagnostic results) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE Systems Rapid TSH (REF LKRT1, LKRT5, L2KRT2, L2KRT6). The product is intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). The recall involves 13,462 units.
The recall was initiated because a rare variant of TSH, identified in a small cluster of patients, is not detected by the device. 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 for further instructions regarding the recall and replacement of the affected units.
The recalled product
- Product
- IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 13,462
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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