Waltham, MA, United States
Nova Biomedical Corporation recalls
3 recalls recorded since 2018, most recently on 29 July 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 29 July 2026
- Reason
- 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.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3131-2026, Z-3130-2026, Z-3128-2026, Z-3132-2026, Z-3129-2026
- StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
- StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
- StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
- StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
- StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Ongoing Class I Medical devices
- Recall started
- 20 November 2024
- Reason
- A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
- Distribution
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0681-2025, Z-0683-2025, Z-0682-2025
- StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
- StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
- StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Ongoing Class II Medical devices
- Recall started
- 18 September 2023
- Reason
- Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
- Distribution
- Nationwide Foreign: Country Algeria Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Croatia CYPRUS Czech Republic Ecuador Egypt El Salvador Finland France Germany Greece Guatemala India Indonesia Ireland Israel Italy Japan JORDAN Kazakhstan Kenya Kurdistan, Iraq Kuwait
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0208-2024, Z-0207-2024
- Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile
- Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus A
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.