Siemens ADVIA Chemistry Iron_2 Reagents Recalled for Potential Measurement Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Iron_2 Reagents due to a potential positive bias in test results that could affect the accuracy of Quality Control and patient iron level measurements.
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 medical device with potential for inaccurate test results but no reported illnesses or injuries documented. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Iron_2 (IRON_2) Reagents used in clinical laboratory testing. The recalled products include Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests). Affected lot numbers are 612584, 625096, 612579, 625091, 635826, and 635821. Approximately 4,966 reagents were distributed in the United States and globally.
The recall is due to a potential for positive bias in Quality Control and patient sample test results when using some IRON_2 reagent wedge pairs. This bias may cause iron level measurements to read higher than actual values, and the magnitude of the bias may vary from one reagent wedge pair to another.
Laboratories and healthcare facilities using the identified lot numbers of ADVIA Chemistry Iron_2 Reagents should stop using the affected product and contact Siemens Healthcare Diagnostics for replacement or corrective action instructions. Clinical personnel should review any test results produced with the recalled reagent lots to determine whether re-testing or other corrective measures are necessary.
The recalled product
- Product
- ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-bias
- test-result-inaccuracy
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)
- (6 x 350 tests) UDI-DI: 00630414561974
- (7 x 145 tests) UDI-DI: 00630414513157
- Lot Numbers: 612584 625096 612579 625091 635826 635821
Distribution
Distributed nationwide across the United States.
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