Siemens Factor IX Plasma Reagent Recalled for Inaccurate Low-Range Results
Siemens Healthcare Diagnostics is recalling Factor IX plasma reagents for the BCS/BCS XP system due to erroneously high results at the lower end of the measuring range.
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 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to inaccurate diagnostic results, which fits the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,575 units of Factor deficient plasma for the Siemens BCS / BCS XP System. This in vitro diagnostic reagent is used to determine the activity of coagulation factor IX in human plasma by coagulometric methods.
The recall was initiated because of discrepancies identified during dilution studies, which resulted in erroneously high Factor IX results at the lower end of the measuring range. The affected product codes are 10454742, 10454729, 10461894, and 10470625.
The product was distributed worldwide, including in the United States, Canada, Mexico, and numerous countries in Europe, South America, the Middle East, and Asia. Healthcare facilities and laboratories that use the Siemens BCS or BCS XP system should stop using the affected reagents and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 3,575
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)
- 10454742 10454729 10461894 10470625
Distribution
Distribution scope not specified by the agency.
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