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NOVA BIOMEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 200 Prospect St, WALTHAM, MA, 02454
Website: novabio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)545-6682
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1219029
DUNS Number: 070617139

Catalogue (629)

Page 1 of 13

Device	Model / Reference	Registries	Class	Status
Stat Profile	PHOX ULTRA/CCX	FDA UDI	Class I	Active
Stat Profile	PHOX PLUS L	FDA UDI	Class II	Active
Stat Profile	PRIME	FDA UDI	Class II	Active
Nova	1/5/11/13	FDA UDI	Class II	Active
Nova Max	GLU	FDA UDI	Class II	Active
Nova	Co-Ox	FDA UDI	Class I	Active
Stat Profile	PHOX ULTRA	FDA UDI	Class II	Active
Stat Profile	PHOX/BASIC/BIOPHOX	FDA UDI	Class II	Active
Nova	10	FDA UDI	Class II	Active
Stat Profile	PRIME ABG	FDA UDI	Class I	Active
Stat Profile	PHOX PLUS/C	FDA UDI	Class II	Active
Stat Profile	Prime	FDA UDI	Class II	Active
Nova	SUREFLEX	FDA UDI	Class II	Active
Statsensor	1.0	FDA UDI	Class I	Active
Stat Profile	PHOX ULTRA/CCX	FDA UDI	Class II	Active
StatStrip	1.0	FDA UDI	Class I	Active
Nova	1/5/11/13	FDA UDI	Class II	Active
Stat Profile	PHOX PLUS L	FDA UDI	Class I	Active
Nova	STATSTRIP LAC	FDA UDI	Class I	Active
Stat Profile	PRIME	FDA UDI	Class II	Active
Stat Profile	CCX	FDA UDI	Class I	Active
Stat Profile	PHOX PLUS L	FDA UDI	Class I	Active
Nova Primary	Nova Primary Analyzer	FDA UDI	Class II	Active
Stat Profile	CCX	FDA UDI	Class II	Active
StatSensor/StatStrip	1.0	FDA UDI	Class II	Active
Nova	1	FDA UDI	Class II	Active
Stat Profile	PHOX ULTRA/CCX	FDA UDI	Class II	Active
Statsensor	1.0	FDA UDI	Class II	Active
Stat Profile	phox ultra/ccx	FDA UDI	Class I	Active
StatStrip	1.0	FDA UDI	Class II	Active
Nova Max	Plus	FDA UDI	Class I	Active
Nova Max	Plus	FDA UDI	Class II	Active
Stat Profile	PRIME	FDA UDI	Class I	Active
StatSensor/StatStrip	1.75	FDA UDI	Class I	Active
Stat Profile	PHOX PLUS	FDA UDI	Class II	Active
Nova/Stat Profile	PHOX/CO-OX	FDA UDI	Class II	Active
Stat Profile	PHOX ULTRA W/R	FDA UDI	Class II	Active
Stat Profile	PRIME ABG	FDA UDI	Class II	Active
Stat Profile	PHOX PLUS	FDA UDI	Class II	Active
Stat Profile	CCX	FDA UDI	Class I	Active
Stat Profile	PRIME ABG	FDA UDI	Class II	Active
Stat Profile	PRIME CCS	FDA UDI	Class II	Active
Nova	1/4/5/8/10/11/12/13/14	FDA UDI	Class II	Active
Stat Profile	PRIME CCS	FDA UDI	Class II	Active
Stat Profile	PHOX PLUS	FDA UDI	Class II	Active
Nova	10	FDA UDI	Class II	Active
Stat Profile	ULTRA/CCX	FDA UDI	Class II	Active
Statstrip	1.0	FDA UDI	Class II	Active
Nova	Co-Ox	FDA UDI	Class I	Active
Stat Profile	Prime Plus	FDA UDI	Class II	Active

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FDA Recalls (36)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 20, 2024	Z-0683-2025	—	open, classified	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.
Nov 20, 2024	Z-0682-2025	—	open, classified	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.
Nov 20, 2024	Z-0681-2025	—	open, classified	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.
Sep 18, 2023	Z-0207-2024	—	open, classified	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.
Sep 18, 2023	Z-0208-2024	—	open, classified	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.
Jun 19, 2017	Z-2732-2017	—	terminated	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.
Oct 10, 2013	Z-0650-2014	—	terminated	Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Jul 15, 2013	Z-1899-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1898-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1900-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1903-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1905-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1904-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1901-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1897-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1902-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Jul 15, 2013	Z-1906-2013	—	terminated	Reports of false abnormally high glucose readings from test strips
Feb 25, 2013	Z-1154-2013	—	terminated	Glucose test strips reports no result message when tested
Feb 25, 2013	Z-1153-2013	—	terminated	Glucose test strips reports no result message when tested
Feb 12, 2010	Z-1783-2010	—	terminated	Glucose strips report low glucose results
Aug 11, 2008	Z-1328-2009	—	terminated	Erroneous, low creatinine results on CCX analyzer
Feb 21, 2008	Z-1472-2008	—	terminated	Lithium batteries may fail if the glucose or creatinine meters have been dropped.
Nov 2, 2007	Z-0725-2008	—	terminated	Incorrect Results - Creatinine results were lower than the laboratory reference method.
Nov 2, 2007	Z-0724-2008	—	terminated	Incorrect Results - Creatinine results were lower than the laboratory reference method.
Nov 2, 2007	Z-0726-2008	—	terminated	Incorrect Results - Creatinine results were lower than the laboratory reference method.
Sep 17, 2007	Z-0295-2008	—	terminated	Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples
Jan 27, 2006	Z-0578-06	—	terminated	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Jan 27, 2006	Z-0576-06	—	terminated	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Jan 27, 2006	Z-0577-06	—	terminated	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Mar 30, 2004	Z-0827-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0830-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0826-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0828-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Mar 30, 2004	Z-0829-04	—	terminated	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
Sep 22, 2003	Z-0060-04	—	terminated	Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
Sep 22, 2003	Z-0061-04	—	terminated	Degradation of the magnesium sensor could result in low ionozed magnesium patient samples