FDA recall, , High risk
StatStrip Glucose Meters
A software issue can cause the device to retain a previously scanned barcode, so a new patient's glucose result may be assigned to the previous patient's record.
Summary by Recall Canary from the FDA notice
What happened
Nova Biomedical Corporation initiated a global Medical Device Correction on July 24, 2026, for the StatStrip Glucose Hospital Meter System due to a software synchronization/timing issue in the barcode scanning and patient data processing component.
The issue causes the device to intermittently retain a previously scanned barcode, including patient identification (ID) 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. This may cause a glucose result to be associated with the wrong patient.
The correction affects StatStrip Glucose and B- Ketone meters and StatStrip Glucose Hospital Meter Systems, with models including 66429, 63910, 66739, 63685, and 63683. Distribution was worldwide, including the US and countries such as Austria, Belgium, Brazil, Canada, and the United Kingdom. The company began the recall on July 29, 2026, and it was added to the FDA's Enforcement Report on September 11, 2026.
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What to do
If a code on your device is listed below:
- If you have an alternative device, you should stop using the affected device.
- Customers in the United States may contact Nova Biomedical Technical Support at 1-800-545-6682.
- Customers in Canada may call 1-800-263-5999.
- Customers outside the United States or Canada should contact their authorized Nova Biomedical distributor or local sales representative. After every barcode scan, verify on the device that the patient ID displayed is for the patient currently being tested. Confirm that the patient name, date of birth, and other identifying information shown on the Confirm Patient ID screen correspond to the patient whose sample is being collected before pressing Accept.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
StatStrip Glucose Hospital Meter System.
- Model
- 63685
- UDI-DI
- 0038548063685
- Model
- 66739
- UDI-DI
- 00385480636858
StatStrip Glucose and B- Ketone meter.
- Model
- 63683
- Device identifier (UDI)
- 00385480637268
- Model
- 63910
- Device identifier (UDI)
- 00385480664295
- Model
- 66429
- UDI-DI
- 00385480639101
Some entries omit identifying details. Check the notice to confirm which units are affected.
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
- UDI-DI
- 00385480636834
Recall details
- Company began the recall
- Sold in
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.
- Company
- Nova Biomedical CorporationWaltham, Massachusetts
- Hazard
- Software defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99546
- Recall numbers
- Z-3128-2026 to Z-3132-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Announced by the company
Summary updated
