What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Recall Record: Class I Recall: StatStrip Glucose and B- Ketone meter. Model No:… by Nova Biomedical Corporation

Here's the summary: FDA classified a recall by Nova Biomedical Corporation as Class I, reported 20260923. The affected product is StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. (recall number Z-3131-2026). Reason for recall: 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 scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.. Status: Ongoing.

Key facts

Recalling firm	Nova Biomedical Corporation
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Classification	Class I
Recall number	Z-3131-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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 scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Nova Biomedical Corporation. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Nova Biomedical Corporation should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Nova Biomedical Corporation directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Nova Biomedical Corporation’s FDA history

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.

Frequently asked questions

What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
Is StatStrip Glucose and B- Ketone meter. Model No: 63910. Gluc recalled?: Yes. FDA lists a Class I recall by Nova Biomedical Corporation for StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system., reported 20260923, with status "Ongoing." FDA recall number: Z-3131-2026.
What is the recall class for Nova Biomedical Corporation's recall?: FDA classified this recall as Class I. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death.

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Full FDA history for Nova Biomedical Corporation

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). Recall Record: Class I Recall: StatStrip Glucose and B- Ketone meter. Model No:… by Nova Biomedical Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/nova-biomedical-corporation-z-3131-2026-2026-09-23

MLA

"Recall Record: Class I Recall: StatStrip Glucose and B- Ketone meter. Model No:… by Nova Biomedical Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/nova-biomedical-corporation-z-3131-2026-2026-09-23.

Chicago

Argus HQ Research. "Recall Record: Class I Recall: StatStrip Glucose and B- Ketone meter. Model No:… by Nova Biomedical Corporation." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/recall/nova-biomedical-corporation-z-3131-2026-2026-09-23.

BibTeX

@misc{argushq_argushq_ai_recall_nova_biomedical_corporation_z_3131_2026_2026_09_23_2026,
  title = {Recall Record: Class I Recall: StatStrip Glucose and B- Ketone meter. Model No:… by Nova Biomedical Corporation},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/nova-biomedical-corporation-z-3131-2026-2026-09-23},
  note = {Accessed: September 29, 2026}
}

Source: FDA.gov — Recalls ↗