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fda_recall · device_recall · high

Abbott Diagnostics Scarborough, Inc. — Class II recall: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software…

Event date
2026-03-25 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1565-2026
Payload hash
c1c02da939221029f692e255

Summary

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. Status: Ongoing.

Frequently asked questions

Has Abbott Diagnostics Scarborough, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 7 total FDA actions tied to Abbott Diagnostics Scarborough, Inc.: 0 warning letters, 7 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 2026-03-25; Argus observed and indexed it on 2026-07-16.
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). Abbott Diagnostics Scarborough, Inc. — Class II recall: Product Name: ID NOW" Influenza A & B 2  Model/Catalog Number: 427-000  Software…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-diagnostics-scarborough-inc-z-1565-2026
MLA
"Abbott Diagnostics Scarborough, Inc. — Class II recall: Product Name: ID NOW" Influenza A & B 2  Model/Catalog Number: 427-000  Software…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-abbott-diagnostics-scarborough-inc-z-1565-2026.
Chicago
Argus HQ Research. "Abbott Diagnostics Scarborough, Inc. — Class II recall: Product Name: ID NOW" Influenza A & B 2  Model/Catalog Number: 427-000  Software…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-diagnostics-scarborough-inc-z-1565-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_diagnostics_scarborough_inc_z_1565_2026_2026,
  title = {Abbott Diagnostics Scarborough, Inc. — Class II recall: Product Name: ID NOW" Influenza A & B 2  Model/Catalog Number: 427-000  Software…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-diagnostics-scarborough-inc-z-1565-2026},
  note = {Accessed: July 23, 2026}
}

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