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Nova Biomedical Recalls
19 recalls on record · May 1, 2013 to January 1, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 1, 2025Medical DevicesFDA
Nova Biomedical Corporation recalls StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ket
Hazard: A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone 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 test result to the DMS.
January 1, 2025Medical DevicesFDA
Nova Biomedical Corporation recalls StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter
Hazard: A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone 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 test result to the DMS.
January 1, 2025Medical DevicesFDA
Nova Biomedical Corporation recalls StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati
Hazard: 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.
November 8, 2023Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,
Hazard: 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.
November 8, 2023Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an
Hazard: 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.
July 19, 2017Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile
Hazard: Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.
January 15, 2014Medical DevicesFDA
Nova Biomedical Corporation recalls Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Cr
Hazard: Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Te
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strip
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips
Hazard: Reports of false abnormally high glucose readings from test strips
August 21, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Stri
Hazard: Reports of false abnormally high glucose readings from test strips
May 1, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Hazard: Glucose test strips reports no result message when tested
May 1, 2013Medical DevicesFDA
Nova Biomedical Corporation recalls Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Hazard: Glucose test strips reports no result message when tested