5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting medical device verification materials for an anticoagulant drug. Degradation of bivalirudin in controls and calibrators poses risk of inaccurate dosing decisions, but no reported injuries or illnesses in the source text.
Plain-English summary
The U.S. Food and Drug Administration has announced a recall of the 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905, manufactured by Aniara Diagnostica LLC. This verification kit is used in medical settings to ensure accurate testing of bivalirudin, a prescription anticoagulant medication.
The recall is being issued due to stability issues identified 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. This degradation could affect the accuracy of test results used to verify bivalirudin dosing and quality control measurements.
The affected product has lot number KE132603 with UDI-DI 05070002420378 and was distributed nationwide in the United States in the states of Illinois, North Carolina, and Tennessee. Healthcare facilities and laboratories using this verification kit should discontinue use and contact the manufacturer for replacement options.
Consumers should be aware that this recall affects medical facilities and laboratories, not consumer products. If you are a healthcare provider or laboratory using this specific kit, you should stop using it immediately and contact Aniara Diagnostica LLC for instructions on returning the product and obtaining a replacement.
The recalled product
- Product
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 4
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: 05070002420378
- Lot Number: KE132603
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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