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fda_recall · device_recall · critical

Nova Biomedical Corporation — Class I recall: StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.

Event date
2026-09-23 00:00:00Z
Observed
2026-09-29 04:20:32Z
Source ID
Z-3130-2026
Payload hash
faa259a9257d89dd9e8c0728…

Summary

A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is sc… Status: Ongoing.

Frequently asked questions

Has Nova Biomedical Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 5 total FDA actions tied to Nova Biomedical Corporation: 0 warning letters, 5 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 critical severity by Argus HQ. FDA published the underlying record on 2026-09-23; Argus observed and indexed it on 2026-09-29.
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). Nova Biomedical Corporation — Class I recall: StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-nova-biomedical-corporation-z-3130-2026
MLA
"Nova Biomedical Corporation — Class I recall: StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-nova-biomedical-corporation-z-3130-2026.
Chicago
Argus HQ Research. "Nova Biomedical Corporation — Class I recall: StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-nova-biomedical-corporation-z-3130-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_nova_biomedical_corporation_z_3130_2026_2026,
  title = {Nova Biomedical Corporation — Class I recall: StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-nova-biomedical-corporation-z-3130-2026},
  note = {Accessed: September 29, 2026}
}

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