This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Names
- StatStrip Glucose Hospital Meter System
- StatStrip Glucose/Ketone Hospital Meter System (distributed only outside U.S.)
- StatStrip Glucose/Ketone (mmol/L) Hospital Meter System (distributed only outside U.S.)
- Unique Device Identifier (UDI)/Part Numbers:
- UDI-DI (01)10385480636858, PN63685
- UDI-DI (01)38548063685, PN63683 (Outside U.S.)
- UDI-DI (01)1038548063910, PN63910 (Outside U.S.)
- Software Versions: All versions from v0.0.13.10 to v0.0.13.44.
What to Do
- Be aware of this issue; however, no action is needed. Meters in use have received a meter software update correction. Other meters will be updated by Nova Biomedical or the local dealer before being put into clinical use.
- On November 20, 2024, Nova Biomedical sent all affected customers an Urgent Field Correction Notice that included the following information:
- Nova Biomedical became aware of the potential risk of meters transmitting incorrect glucose and ketone patient test results to a healthcare system’s data management system due to a software defect.
- Current Nova StatStrip customers that have gone “Live” with their new meters recently received a meter software update (v.0.0.13.45 or above) from Nova Biomedical to eliminate the potential risk.
- Remaining customers with affected StatStrip meters will have their meter software updated by Nova Biomedical or a local dealer prior to going “Live” with your new meters.
- A Nova Biomedical representative or the local distributor will perform the update and document completion of the update during the implementation process.
- Customers should:
- Distribute the correction notice to those in the organization who need to be aware and those at other facilities who may have received these meters from your organization.
- If the notice is forwarded to other facilities, also notify Nova Biomedical Technical Support at 1-800-545-6682 to make sure the firm is able to update firmware on meters that were transferred or distributed.
- Report any similar incorrect data transfers occurrences to Nova Biomedical Technical Support at the number above.
- On December 16, 2024, Nova Biomedical sent all affected customers a revised Urgent Field Correction Notice to provide the following additional information:
- This issue may affect certain historical glucose test results in a hospital’s medical record system.
- The ability to identify and fix incorrect test results in hospital medical record systems is likely not possible.
- Software versions v0.0.13.10 to v0.0.13.44 are affected.
- Ketone results would also be impacted by the software defect, but no Glucose/Ketone meters were operational at the time this issue was identified and corrected.
Reason for Correction
Nova Biomedical is correcting StatStrip Glucose and Glucose/Ketone Hospital Meters due to the potential risk that a software error may cause incorrect glucose and/or ketone patient test results to be transmitted to hospital medical record systems. The issue occurs when an operator visits the “Review Results” screen to review previous historical test results while the meter is still in the process of transmitting current results wirelessly to the system. The issue may affect all historical test results within the system before the meters are updated to v.0.0.13.45 software.
The use of affected product may cause serious adverse health consequences due to treatment decisions made based on incorrect blood glucose and/or ketone levels, which can result in low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), or high levels of ketones in the blood (ketonemia or ketoacidosis).. This risk of serious adverse health consequence is elevated in a subset of the intended use population, which includes neonates and patients receiving intensive medical care.
There have been no reported injuries. There have been no reports of death.
Device Use
The StatStrip Glucose Hospital Meter System is used in hospitals and health care settings to measure glucose in a patient’s blood. The meter can measure glucose in samples collected from a finger stick, a blood vessel, or a newborn’s heel stick. It is used for adults, children and newborns, including patients who are receiving critical care support. The StatStrip Glucose/Ketone Hospital Meter System and StatStrip Glucose/Ketone (mmol/L) Hospital Meter system also measure ketones in the patient's blood and are only distributed outside the U.S.
Contact Information
Customers in the U.S. with questions about this recall should contact Nova Biomedical Corporation Technical Support at 1-800-545-6682.
Additional FDA Resources
Additional Company Resources
Company provided information on a recall, is posted here by the FDA as a public service.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
