United StatesStatStrip Glucose Hospital Meter System and StatStrip Glucose and B‑Ketone meters (Model Nos. 63685, 66739, 63683, 63910, 66429; software versions 0.00.13.10 through 1.5.14.25; listed UDI‑DIs) are being recalled. A software synchronization/timing issue can cause the device to retain a previously scanned patient or QC barcode so a current test result may be assigned to the wrong patient or identifier (analytical glucose accuracy is not affected).
What's being recalled
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Recalling firm: Nova Biomedical Corporation, Waltham, MA, United States.
How to identify it
Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25. Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25. Model No: 63683. UDI-DI: 00385480636834. Software Versions: All versions 0.00.13.10 through 1.5.14.25. Model No: 63910. UDI-DI: 00385480639101. Software Versions: All versions 0.00.13.10 through 1.5.14.25. Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
The hazard
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 to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada