Siemens IMMULITE Testosterone Assay Recalled for Measurement Bias
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
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 recall involving a confirmed 40% positive measurement bias in a diagnostic assay. No illnesses or injuries have been reported. The recall meets the High severity criterion as a risk-of-harm product where injury has not yet been reported, with the primary consequence being diagnostic delay requiring repeat testing.
Plain-English summary
Siemens Healthcare Diagnostics is recalling two lots of its IMMULITE and IMMULITE 1000 Total Testosterone Assay, a laboratory diagnostic test. The recall affects lot numbers 515 and 516, totaling 867 distributed units.
The assay showed a confirmed average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL and above when compared to the IMMULITE 2000 assay. While testosterone measurements are typically interpreted alongside clinical history and other laboratory tests, this measurement error may cause delays in diagnosis and require patients to undergo repeat testing.
The affected assay kits were distributed to customers nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various locations in Europe, Asia, and South America.
Patients, healthcare providers, and laboratories that used these specific lot numbers should contact Siemens or their healthcare provider. Repeat testing using alternative diagnostic methods may be necessary to verify accurate testosterone levels and support timely clinical care.
The recalled product
- Product
- IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 867
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 (4)
- UDI: (01)00630414964782(10)0515(17)20221130
- (01)00630414964782(10)0516(17)20221231 Lot Numbers: 515
- Exp Date: 2022-11-30 516
- Exp Date: 2022-12-31
Distribution
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