5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may 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, which involves a remote possibility of adverse health consequences, and involves a low-risk contamination/stability issue.
Plain-English summary
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control, Model Number 5D-44905, due to identified stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix.
These stability issues can lead to the degradation of measurable bivalirudin within the controls, calibrators, and linearity values. This affects 9 units distributed nationwide in the states of IL, NC, and TN.
Users should check their inventory for the affected lot number and contact the manufacturer for further guidance.
The recalled product
- Product
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 9
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: 05070002420385
- Lot Number: KE132602
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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