Siemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.
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: This is an FDA Class II medical device recall involving inaccurate test results with no reported illnesses or injuries. The hazard represents a risk of diagnostic error, meeting the criterion for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 Anti-TG Ab test kits (Catalog # L2KTG6, 600 Tests per kit) used to measure thyroid autoantibodies. The affected product lots are 785, 790, 791, and 793.
The test kits may produce falsely elevated patient sample results, which could lead to inaccurate diagnosis or treatment decisions related to thyroid autoimmune disease.
Approximately 488 units of the affected lots were distributed worldwide, including 33 units across multiple U.S. states and 455 units to international locations. Healthcare facilities and laboratories that have received these lots should contact Siemens Healthcare Diagnostics for guidance.
The recalled product
- Product
- IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (7)
- Catalog # L2KTG6
- SMN 10381655
- UDI/DI: 00630414962115
- Lot #s: 785
- 790
- 791
- 793.
Distribution
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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