Nova Biomedical Corporation: Prescription Use Blood Glucose Meter For Near-patient Testing
Recall Summary Nova Biomedical's StatStrip Glucose and B-Ketone meter (Model 63910) is being recalled due to a software glitch that can cause the device to display a previous patient's barcode information when scanning a new barcode, leading to test results being recorded in the wrong patient's medical record. This creates two risks: the current patient won't have their glucose result recorded, and the previous patient may receive incorrect treatment based on someone else's test result. The recall affects meters distributed nationwide in the US and in multiple countries worldwide.
- Recalling firm
- Nova Biomedical Corporation
- Product
- StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
- Reason
- 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...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f5d321ba-d070-4f45-92e9-abdaef5a4f94