Nova Biomedical / ADLM 2025 (archive; crop).
Nova Biomedical’s October 5 safety notice told hospitals to stop using affected StatStrip Gen 2.0 glucose meters when an alternative is available, after a software issue was linked to results being assigned to the wrong patient’s record. The FDA now classifies the removal as its most serious type of recall.
The FDA’s recall notice says Nova reported one serious injury and no deaths associated with the issue as of October 5. This is an update on an existing safety action, not a newly announced November 1 recall.
The problem affects the most recent Gen 2.0 StatStrip Glucose Hospital Meter System, including model 63685 and the 66739 multipack. Earlier models are not covered. All firmware versions on the affected generation are involved.
A correct measurement can reach the wrong chart
The issue does not affect the analytical performance of glucose measurements, according to the FDA. Instead, information from an earlier patient or quality-control barcode may remain on the screen after a scan. If that information is accepted, the next glucose result can be attached to the wrong patient’s medical record or quality-control ID.
That creates a risk of clinicians acting on someone else’s reading. The FDA says possible consequences include delayed treatment, unnecessary treatment such as inappropriate insulin administration, or failure to treat the patient whose sample was tested. Critically ill patients and infants may face greater risk because they may be unable to communicate symptoms of low blood sugar.
What hospitals are being told to do
Where a replacement device is available, the FDA says users should stop using the affected meter. If there is no alternative, facilities must keep following the listed mitigation steps until the software fix is available.
Those steps include checking the patient’s identity after every barcode scan and checking it again when the glucose result appears. Staff should not assume that the identity on the result screen matches the one verified during scanning.
The notice also calls for automatic operator logout after each test, patient-ID validation where supported by integrated admission, discharge and transfer information, and immediate reporting of misassigned results to an administrator. Incorrect chart entries should be flagged or removed under the facility’s procedures, with the treating clinical team notified promptly.
Nova’s revised October 5 customer advisory replaces its July notice. The company has placed a shipment hold on the affected new model while corrective work is developed and validated.
Nova intends to roll out a software update in phases during November 2026. That is a planned fix, not confirmation that corrected software is already available at every hospital. U.S. customers with questions or adverse events can contact Nova Biomedical at 1-800-545-6682.
JBizNews Desk | Washington
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