Skip to main content

fda_recall · device_recall · high

Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

Event date
2024-04-10 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1476-2024
Payload hash
c08636b331d9e3d36687e880…

Summary

The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction. Status: Ongoing.

Entities

View source record ↗

Frequently asked questions

Has Abbott Laboratories had other FDA enforcement actions?
Yes. Argus HQ has recorded 15 total FDA actions tied to Abbott Laboratories: 0 warning letters, 15 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 2024-04-10; 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 (2024). Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-laboratories-z-1476-2024
MLA
"Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbott-laboratories-z-1476-2024.
Chicago
Argus HQ Research. "Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-laboratories-z-1476-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_laboratories_z_1476_2024_2024,
  title = {Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-laboratories-z-1476-2024},
  note = {Accessed: July 23, 2026}
}

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

Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. · Argus HQ