Aniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
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, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk of inaccurate test results rather than direct physical harm.
Plain-English summary
Aniara Diagnostica LLC is recalling 7 units of the 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905. The recall is due to identified stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix.
These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. The affected product is identified by UDI-DI 05070002420392 and Lot Number KE132601.
The product was distributed nationwide in the United States, specifically in the states of Illinois, North Carolina, and Tennessee. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 7
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 (2)
- UDI-DI: 05070002420392
- Lot Number: KE132601
Distribution
Part of a larger recall action
This product is one of 3 recalled by Aniara Diagnostica LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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