Summary
The FDA issued a Class II for 5-PLASMA Bivalirudin Control, Model Number 5D-44905 by Aniara Diagnostica LLC. Reason: Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degrada.
Details
Source
Device Recall
External ID
Z-2896-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Lot/Code Info: UDI-DI: 05070002420385, Lot Number: KE132602
Quantity Affected: 9 units
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.
Distribution
US Nationwide distribution in the states of IL, NC, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-01
Company
West Chester, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Aniara Diagnostica LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aniara Diagnostica LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aniara Diagnostica LLC have FDA actions?
Aniara Diagnostica LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2896-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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