Nova StatStrip Glucose Hospital Meter System Recalled for Software Defect
Nova Biomedical is recalling StatStrip Glucose Hospital Meter Systems due to a software defect that may cause patient glucose results to be assigned to the wrong medical record.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency has classified this as a Class I recall, which mandates a severity score of 5 per the rubric.
Plain-English summary
Nova Biomedical Corporation is recalling the StatStrip Glucose Hospital Meter System, Model No. 63685. The recall involves 20,616 units 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 causes 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 remains displayed on the screen for the current test. If an operator accepts this incorrect information, the current patient's glucose result may be assigned to the previous patient's medical record, while the current patient's record receives no 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 of the StatStrip Glucose Hospital Meter System should contact Nova Biomedical Corporation for instructions on how to resolve the software defect. The agency has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
- Manufacturer
- Nova Biomedical Corporation
- Affected units
- 20,616
Distribution
Distributed nationwide across the United States.
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