Siemens Atellica IM aTG Test Kits Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling 1,489 Atellica IM aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,489 units of the Siemens Atellica IM aTG (100 test kit), identified by Siemens Material Number (SMN) 10995461. The recall affects specific kit lots ending in 317 and lower, including lots 72259303, 87903305, 94908307, 96439307, 16824309, 25822309, 28942311, 55978313, and 70389317, with expiration dates ranging from December 13, 2018, to June 29, 2019.
The recall was initiated because the affected kits exhibit positive bias in anti-thyroglobulin measurements when compared to the standardization to the World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU). This discrepancy may result in inaccurate test results for patients.
The affected products were distributed nationwide and to various foreign locations. Healthcare facilities and laboratories that have received these specific lots should stop using them and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 1,489
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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