FDA Classifies Recall of Aniara Diagnostica Verification Kits as Class II
The FDA has designated an ongoing recall of four bivalirudin verification kit units as Class II.
3 reports on this incident · first at Aug 18, 2026, 1:54 a.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
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Earlier reports
Aug 18, 2026, 1:56 a.m. ET
FDA Closes Recall Action for Aniara Diagnostica Bivalirudin Verification Kits
The Food and Drug Administration has closed its recall action for four units of the 5-PLASMA Bivalirudin AMR Verification Kit produced by Aniara Diagnostica LLC, meaning the agency considers the recall carried out.
The recall, designated Z-2894-2026, was initiated on July 1, 2026, and reported as a Class II action on August 12, 2026. Under FDA definitions, a Class II recall involves products that may cause temporary or medically reversible adverse health consequences, with a remote chance of serious harm. FDA listings show no other enforcement actions associated with Aniara Diagnostica LLC.
FDA enforcement reports stated that the action was taken due to stability issues in the reconstituted lyophilized human plasma and bivalirudin matrix, which caused degradation of measurable bivalirudin in controls, calibrators, and linearity values. For laboratory staff checking remaining inventory, the affected kit carries Model Number 5D-45905, Lot Number KE132603, and UDI-DI 05070002420378. Distribution covered IL, NC, and TN. Reference information from Mayo Clinic Laboratories notes that the product is a professional clinical laboratory testing kit used to evaluate assay measurement ranges and is not sold to retail consumers.
Aug 18, 2026, 1:54 a.m. ETFirst report
FDA Reports Class II Recall for Aniara Diagnostica Diagnostic Kits
Aniara Diagnostica LLC initiated a recall on July 1, 2026, for four units of its 5-PLASMA Bivalirudin AMR Verification Kit, according to an FDA enforcement report published August 12, 2026. The action, listed under recall number Z-2894-2026, is open and ongoing.
The recall is classified as Class II. According to FDA definitions, a Class II recall applies to situations where a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is remote. FDA enforcement documentation lists no other enforcement actions for Aniara Diagnostica LLC.
The affected units carry Model Number 5D-45905, Lot Number KE132603, and UDI-DI 05070002420378. Distribution was nationwide to Illinois, North Carolina, and Tennessee. The FDA report states the recall was initiated due to stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix, which lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
According to reference data from laboratory trade and testing organizations, the kit is a professional in-vitro diagnostic tool containing five plasma samples used by hospital, reference, and public-health laboratories to verify instrument measurement ranges. The material is consumable laboratory equipment and is not sold directly to consumers.
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- Version 118 Aug 2026, 05:54current
First published.
- Version 118 Aug 2026, 06:27current
First published.
- Version 118 Aug 2026, 05:56current
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