StatStrip Glucose and B- Ketone meter recall
Nova Biomedical Corporation recalled StatStrip Glucose and B- Ketone meter on September 23, 2026 because of 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. It was sold nationwide.
Why it was recalled
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 wi…
What's recalled
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Quantity: 8,939 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Nova Biomedical Corporation, Waltham, MA
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- Nationwide
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. - Status
- Ongoing
- Recall number
- Z-3131-2026
- Source
- U.S. Food and Drug Administration
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