Atellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias
Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.
What this means for you
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: This recall concerns a diagnostic test with measurement bias that could lead to inaccurate patient test results, meeting the rubric criterion of a risk-of-harm product. Although no illnesses or injuries have been reported, the positive bias affecting results at the diagnostic cut-off level could produce false positive findings that impact clinical decision-making.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 9783 kits of the Atellica IM aTPO Assay (Material Numbers 10995466 and 10995467), a diagnostic test used in clinical laboratories.
The recall addresses positive bias in patient test results from certain lots. When results from affected lots are compared to results from other lots run on the same Atellica IM analyzer, patient results at and below the 60 U/mL cut-off show positive bias.
The affected product (Lot Numbers 26098336 and 26099336) has been distributed worldwide and throughout the United States.
Laboratory professionals and healthcare providers should contact Siemens Healthcare Diagnostics for handling instructions. The FDA classified this recall as Class II.
The recalled product
- Product
- Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 9,783
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 (3)
- UDI-DI: Material Number 10995466 (100 Test) - 00630414597935
- Material Number 10995467 (500 Test) - 00630414597942
- Lot Number: 26098336 26099336
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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