Has Alere San Diego, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Alere San Diego, Inc.: 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 2026-10-07; Argus observed and indexed it on 2026-10-13.

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

Alere San Diego, Inc. — Class II recall: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cass…

Name: FDA Recall Record — Alere San Diego, Inc.
Creator: Argus HQ
Published: 2026-10-07
License: https://argushq.ai/methodology

Event date: 2026-10-07 00:00:00Z
Observed: 2026-10-13 04:20:41Z
Source ID: Z-3271-2026
Payload hash: 00998ca97240bc9d85855c09…

Summary

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Status: Ongoing.

Entities

Alere San Diego, Inc.

View source record ↗

Frequently asked questions

Has Alere San Diego, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Alere San Diego, Inc.: 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 2026-10-07; Argus observed and indexed it on 2026-10-13.
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). Alere San Diego, Inc. — Class II recall: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;  Alere hCG Cass…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-alere-san-diego-inc-z-3271-2026

MLA

"Alere San Diego, Inc. — Class II recall: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;  Alere hCG Cass…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-alere-san-diego-inc-z-3271-2026.

Chicago

Argus HQ Research. "Alere San Diego, Inc. — Class II recall: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;  Alere hCG Cass…." Digital Empire Holdings LLC. Accessed October 13, 2026. https://argushq.ai/events/fda-recall-alere-san-diego-inc-z-3271-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_alere_san_diego_inc_z_3271_2026_2026,
  title = {Alere San Diego, Inc. — Class II recall: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;  Alere hCG Cass…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-alere-san-diego-inc-z-3271-2026},
  note = {Accessed: October 13, 2026}
}

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