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 2026-05-20; Argus observed and indexed it on 2026-07-09.

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: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Name: FDA Recall Record — Aniara Diagnostica LLC
Creator: Argus HQ
Published: 2026-05-20
License: https://argushq.ai/methodology

Event date: 2026-05-20 00:00:00Z
Observed: 2026-07-09 22:52:31Z
Source ID: Z-2171-2026
Payload hash: 338e513ab5c0af8123be4a00…

Summary

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. 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 2026-05-20; Argus observed and indexed it on 2026-07-09.
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: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2171-2026

MLA

"Aniara Diagnostica LLC — Class II recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2171-2026.

Chicago

Argus HQ Research. "Aniara Diagnostica LLC — Class II recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2171-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_aniara_diagnostica_llc_z_2171_2026_2026,
  title = {Aniara Diagnostica LLC — Class II recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-aniara-diagnostica-llc-z-2171-2026},
  note = {Accessed: August 27, 2026}
}

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