How many FDA warning letters has Aniara Diagnostica LLC received?

Argus HQ has not recorded an FDA warning letter for Aniara Diagnostica LLC in our current dataset.

What FDA recalls has Aniara Diagnostica LLC issued?

Argus HQ has recorded 1 FDA recall tied to Aniara Diagnostica LLC.

Is Aniara Diagnostica LLC FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Aniara Diagnostica LLC. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Aniara Diagnostica LLC

Name: FDA Enforcement Actions Against Aniara Diagnostica LLC
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-05-20
Aniara Diagnostica LLC — Class II recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Frequently asked questions

How many FDA warning letters has Aniara Diagnostica LLC received?: Argus HQ has not recorded an FDA warning letter for Aniara Diagnostica LLC in our current dataset.
What FDA recalls has Aniara Diagnostica LLC issued?: Argus HQ has recorded 1 FDA recall tied to Aniara Diagnostica LLC.
Is Aniara Diagnostica LLC FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Aniara Diagnostica LLC. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.