FDA Medical devices recall ·
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 recall
- Recall number
- Z-2895-2026
- Date
- (initiated July 1, 2026)
- Company / brand
- Aniara Diagnostica LLC
7768 Service Center Dr, West Chester, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 05070002420392, Lot Number: KE132601
Distribution
US Nationwide distribution in the states of IL, NC, TN.
States: Illinois North Carolina Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2895-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.