Has Aniara Diagnostica LLC had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Aniara Diagnostica LLC: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Aniara Diagnostica LLC — Class II recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Name: FDA Recall Record — Aniara Diagnostica LLC
Creator: Argus HQ
Published: 2026-08-12
License: https://argushq.ai/methodology

Event date: 2026-08-12 00:00:00Z
Observed: 2026-08-19 04:20:40Z
Source ID: Z-2894-2026
Payload hash: d9c0c76da3ae7802ba6ea771…

Summary

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. Status: Ongoing.

Entities

Aniara Diagnostica LLC

View source record ↗

Frequently asked questions

Has Aniara Diagnostica LLC had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Aniara Diagnostica LLC: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Aniara Diagnostica LLC — Class II recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2894-2026

MLA

"Aniara Diagnostica LLC — Class II recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2894-2026.

Chicago

Argus HQ Research. "Aniara Diagnostica LLC — Class II recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2894-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_aniara_diagnostica_llc_z_2894_2026_2026,
  title = {Aniara Diagnostica LLC — Class II recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2894-2026},
  note = {Accessed: August 19, 2026}
}

Informational only. Not legal, financial, or medical advice.