Siemens IMMULITE TBG Test Kits Recalled for Inaccurate Results
Siemens Healthcare Diagnostics is recalling 155 IMMULITE TBG test kits because they may produce falsely low thyroid test results.
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 that may produce inaccurate diagnostic results (depressed TBG values), which poses a risk of harm through misdiagnosis or improper treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 155 kits of the IMMULITE/IMMULITE 1000 Systems TBG (catalog LKTB1). The affected product is used for the quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum to aid in the diagnosis and treatment of thyroid diseases.
The recall was initiated because the specific lot of the product is failing the adjustment slope instrument parameter. The resulting slope of the kit is greater than 1.80, which creates the potential to produce depressed TBG patient values. This means the test may report lower levels of TBG than are actually present in the patient's serum.
The affected units are identified by LOT 0257 and SMN 10381643. These kits were distributed worldwide to Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China, and the Russian Federation. Healthcare facilities and laboratories should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 155
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 (2)
- LOT 0257
- SMN 10381643
Distribution
Distribution scope not specified by the agency.
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