Thyroid Autoantibody Test System Recalled for Falsely Elevated Results
Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.
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: FDA Class II recall with potential for inaccurate diagnostic test results that could lead to patient misdiagnosis. This qualifies as a risk-of-harm product where no injuries have been reported, meeting the criterion for High severity.
Plain-English summary
The IMMULITE 2000 Anti-TG Ab is a thyroid autoantibody diagnostic test system manufactured by Siemens Healthcare Diagnostics, Inc. Specific lot numbers of this test are being recalled due to a quality issue affecting result accuracy.
Affected lot numbers (782, 783, 785, 786, 787, 788, 789, 790, 791, 792, and 793) have the potential to produce falsely elevated patient sample results. Inaccurate test results could lead to incorrect medical decisions and misdiagnosis based on incorrectly elevated thyroid antibody measurements.
Approximately 2,956 units of the affected test kits have been distributed worldwide, including 463 units in the United States and 2,493 units internationally, to healthcare facilities and diagnostic laboratories.
Healthcare providers and laboratories using the affected lot numbers should discontinue use and contact Siemens Healthcare Diagnostics, Inc. for guidance on replacement test kits or other corrective measures.
The recalled product
- Product
- IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- inaccurate-test-results
- diagnostic-error
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 (12)
- Catalog # L2KTG2
- SMN 10381659
- UDI/DI: 00630414962108
- Lot #s: 782
- 783
- 786
- 787
- 788
- 789
- 791
- 792
- 793.
Distribution
Distributed nationwide across the United States.
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