OVERLOOKED

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Class IIOngoing

Aniara Diagnostica LLC recalls 3 products

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Aniara Diagnostica LLC
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of IL, NC, TN.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99344…

Products (3)

  1. 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

    Codes/lots: UDI-DI: 05070002420378, Lot Number: KE132603Quantity: 4 unitsRecall no. Z-2894-2026Class II

  2. 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

    Codes/lots: UDI-DI: 05070002420392, Lot Number: KE132601Quantity: 7 unitsRecall no. Z-2895-2026Class II

  3. 5-PLASMA Bivalirudin Control, Model Number 5D-44905

    Codes/lots: UDI-DI: 05070002420385, Lot Number: KE132602Quantity: 9 unitsRecall no. Z-2896-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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