Siemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
Siemens Healthcare Diagnostics is recalling specific lots of BC Thrombin Reagent Kits because they may produce unexpectedly prolonged Thrombin Time results for normal samples.
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 (prolonged Thrombin Time) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving potential misdiagnosis or treatment delays without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics is recalling two lots of BC Thrombin Reagent Kits (Lot 46751 and Lot 47184) due to a defect in the reagent performance. The affected kits contain Thrombin Reagent lots 517468 and 517469, respectively.
The recall was initiated because these specific lots may produce unexpectedly prolonged Thrombin Time (TT) results for samples that are expected to be normal. The results may recover to above the upper limit of normal, which is stated as less than 21 seconds in the Instructions for Use (IFU). This product is intended for in vitro diagnostic use for the quantitative determination of thrombin time in citrated human plasma.
A total of 7,631 units were distributed worldwide, including the United States, Canada, Australia, and numerous countries in Europe, the Middle East, and South America. Users of these specific lots should stop using the product and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative de
- Manufacturer
- Siemens Healthcare Diagnostics
- Affected units
- 7,631
Distribution
Distributed nationwide across the United States.
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