5-PLASMA Bivalirudin AMR Verification Kit recall: Impurity Out of Spec
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Why was 5-PLASMA Bivalirudin AMR Verification Kit recalled?
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 05070002420378, Lot Number: KE132603
- Product
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
- Recall date
- August 12, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)