FDAFDA recall Z-2896-2026 · Aug 12, 2026
Aniara Diagnostica LLC: 5-PLASMA Bivalirudin Control recall
Recall found
Product
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 05070002420385, Lot Number: KE132602
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
- Recalling firm
- Aniara Diagnostica LLC, West Chester, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-01
Source: openFDA enforcement record Z-2896-2026 · search recall number Z-2896-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.