Nova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
Nova Biomedical is recalling StatStrip Glucose and B-Ketone meters due to a software defect that may cause patient data to be assigned to the wrong medical record.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score due to the potential for serious adverse health consequences or death.
Plain-English summary
Nova Biomedical Corporation is recalling 8,939 units of the StatStrip Glucose and B-Ketone meter, Model No. 63910. The recall covers devices distributed worldwide, including the United States and 22 foreign countries. The affected software versions range from 0.00.13.10 through 1.5.14.25.
The recall is due to a software synchronization and timing issue in the barcode scanning and patient data processing component. This defect can cause the device to intermittently retain a previously scanned barcode, including patient identification and quality control barcodes, when a new barcode is scanned. As a result, the prior barcode information may remain displayed on the screen for the current test. If an operator accepts this incorrectly displayed information, the current patient's glucose result may be assigned to the previous patient's medical record, while the current patient's record remains without a result. This can lead to inappropriate clinical interventions based on erroneous data, particularly for critically ill patients, neonates, and infants. The defect does not affect the analytical accuracy of the glucose measurements themselves.
Healthcare facilities and users should stop using the affected devices and contact Nova Biomedical Corporation for instructions on how to proceed. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
- Manufacturer
- Nova Biomedical Corporation
- Category
- Medical Device — Glucose Meter
- Affected units
- 8,939
Distribution
Distributed nationwide across the United States.
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