Siemens ADVIA Chemistry Triglyceride Reagent Recalled for Linearity Defects
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglyceride reagent lots 348297 and 359932 because they fail linearity claims near end of shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate diagnostic results due to linearity defects, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Triglyceride_2, concentrated (TRIG_c) reagent, Catalog # SMN # 10697575. The recall affects 7,433 units, specifically lot 348297 (4,228 units) and lot 359932 (3,199 units). The product is intended for in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
The recall was initiated because the reagent does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life. This defect may result in inaccurate test results for triglyceride levels.
The affected products were distributed worldwide, including in the United States and numerous international countries. Users of these specific lots should stop using the reagent and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (1)
- Kit lots 348297 & 359932.
Distribution
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