Nova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
Nova Biomedical is recalling StatStrip Glucose and B-Ketone meters because a software defect may cause patient data 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Nova Biomedical Corporation is recalling 2,044 units of the StatStrip Glucose and B-Ketone meter, Model No. 66429. The recall covers software versions 0.00.13.10 through 1.5.14.25. The devices were distributed nationwide in the United States and in 22 foreign countries, including Canada, the United Kingdom, and Germany.
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, such as a patient ID or quality control solution ID, when a new barcode is scanned. If an operator accepts the incorrectly displayed patient information, the current patient's glucose result may be assigned to the previous patient's medical record. Consequently, the current patient's record will not receive the result, leaving their glucose status unrecorded. The previous patient may receive inappropriate clinical intervention based on the erroneous result, particularly in critically ill patients, neonates, and infants.
The defect does not affect the analytical accuracy of the glucose measurements themselves. The issue also affects quality control barcode scanning, potentially causing QC results to be attributed to incorrect identifiers or QC tests to fail without the user recognizing the cause. Consumers and healthcare providers should stop using the affected devices and contact Nova Biomedical Corporation for further instructions.
The recalled product
- Product
- StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
- Manufacturer
- Nova Biomedical Corporation
- Affected units
- 2,044
Distribution
Distributed nationwide across the United States.
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