CLASS I ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
StatStrip Glucose Hospital Meter System recalled by Nova Biomedical
Nova Biomedical is recalling StatStrip Glucose Hospital Meter System, distributed nationwide in the US. The recall was initiated on 20 Nov 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0681-2025
- FDA event ID
- 95783
- Recalling firm
- Nova Biomedical, Waltham, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 20 Nov 2024
- FDA classified
- 20 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 20 Nov 2024 | Recall initiated by company | |
| 20 Dec 2024 | Classified by FDA | +30 days |
| 1 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Where it was distributed
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Questions about this recall
Why was it recalled?
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Which lots are affected?
Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
Where was it sold?
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95783| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | StatStrip Glucose Ketone (mmol/L) Hospital Meter System recalled | Nova Biomedical | Device Malfunction | Nationwide | |
| CLASS I | StatStrip Glucose Ketone Hospital Meter System recalled | Nova Biomedical | Device Malfunction | Nationwide |
More recalls from Nova Biomedical
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 466| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |