Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.
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 involves a medical device where a specific hazard (failure to detect a rare TSH variant) exists, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks (REF 06491072, REF 06491080, and REF 04862625). These products are intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). The recall involves 172,913 units.
The recall was initiated because a rare variant of TSH, identified in a small cluster of patients, is not detected by the test. This limitation may result in inaccurate measurement of TSH levels in affected individuals.
The products were distributed worldwide, including the United States (nationwide) and numerous international countries. Healthcare facilities and laboratories should contact Siemens Healthcare Diagnostics for instructions on returning the affected products.
The recalled product
- Product
- ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 172,913
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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