Data / Medical devices / United States / Nova Biomedical Corporation

Nova Biomedical Corporation: FDA-registered device maker in Waltham, MA, United States, 68 510(k) clearances

Name: Nova Biomedical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nova Biomedical Corporation is registered with the FDA (registration 1219029) in Waltham, MA, United States. It lists 57 device types. The FDA files 68 510(k) clearances under its listings, the newest dated November 22, 2024. 15 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Nova Biomedical Corporation

FDA registration number: 1219029
Address: 200 Prospect St, Waltham, MA, United States, 02454
Owner or operator: NOVA BIOMEDICAL CORP. (1219029)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: September 21, 2006
Registered through: 2026
Brand names listed: 42035 Prime Sensor Card ES Comp, 51184 Menarini Glucofix Mio Premium, 51185 Menarini Glucofix Mio Premium, 52853 Prime ES Comp, 53102 Prime Calibrator Cartridge ES Comp 300 Sample, 53103 Prime Calibrator Cartridge ES Comp 100 Sample, 53110 Prime Ampuled Control ES, 53362 Prime Calibrator Cartridge ES Comp 200 Sample and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Lactic, Enzymatic Method	KHP	1	Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer	accessdata.fda.gov
Alkaline Picrate, Colorimetry, Creatinine	CGX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	JJC	1	Manufacturer, Remanufacturer	accessdata.fda.gov
Assay, Carboxyhemoglobin	GHS	2	Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Assay, Fetal Hemoglobin	KQI	2	Manufacturer for export	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Assay, Sulfhemoglobin	GJC	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Manufacturer, Remanufacturer	accessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	1	Manufacturer for export	accessdata.fda.gov
Blood, Occult, Enzymatic Method, In Urine	JIP	2	Manufacturer	accessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit Measurement	KRZ	2	Manufacturer for export	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Calibrator, Pressure, Gas	BXX	1	Manufacturer, Remanufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colorimetric Method, Triglycerides	JGY	1	Manufacturer for export	accessdata.fda.gov
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	1	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Cyanomethemoglobin	GKK	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	JQT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Device, Hematocrit Measuring	JPI	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion Based, Enzymatic, Creatinine	CGL	2	Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion Specific, Magnesium	CFA	1	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion Specific, Urea Nitrogen	CDS	2	Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer for export	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction	JBJ	2	Manufacturer for export	accessdata.fda.gov
Hemoglobinometer	GIG	2	Manufacturer for export	accessdata.fda.gov
Illuminator System For Blood Products	PJF	3	Contract manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Manufacturer for export	accessdata.fda.gov
Instrument, Hematocrit, Automated	GKF	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Manufacturer for export	accessdata.fda.gov
Mixture, Hematology Quality Control	JPK	2	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Oximeter To Measure Hemoglobin	GLY	2	Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Oxyhemoglobin	GGZ	2	Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Ph Rate Measurement, Carbon-Dioxide	JFL	2	Contract manufacturer, Manufacturer, Remanufacturer	accessdata.fda.gov
Prescription Use Blood Glucose Meter For Near-Patient Testing	PZI	2	Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer	accessdata.fda.gov
Retainer, Matrix	JEP	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer	accessdata.fda.gov
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	JKS	1	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
Standards And Controls, Hemoglobin, Normal And Abnormal	GFS	2	Manufacturer for export	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Specification developer	accessdata.fda.gov
Test, Lactic Acid, Over The Counter	NGD	1	Manufacturer, Remanufacturer	accessdata.fda.gov
Test, Time, Prothrombin	GJS	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	JIQ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Uric Acid Test System For At Home Prescription Use	PTC	1	Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export	accessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)	JJW	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 22, 2024	K221326	Nova Allegro HbA1c Assay, Nova Allegro Analyzer	LCP	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
November 19, 2024	K221813	Nova Allegro UACR Assay, Nova Allegro Analyzer	CGX	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
February 23, 2024	K232075	StatStrip Glucose Hospital Meter System	PZI	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
October 18, 2022	K203549	Nova Primary Glucose Analyzer System	CGA	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
August 16, 2019	K191626	Stat Profile Prime ES Comp Plus Analyzer System	JFP	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
July 19, 2019	K191365	Stat Profile Prime ES Comp Plus Analyzer System	JGS	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
September 26, 2018	K180340	Stat Profile Prime Plus Analyzer System	CGA	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
August 23, 2018	K180186	Stat Profile Prime Plus Analyzer System	GGZ	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
August 15, 2018	K180428	Stat Profile Prime Plus Analyzer System	JGS	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
July 17, 2018	K173797	Stat Profile Prime Plus Analyzer System	CHL	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
April 11, 2017	K160990	Nova Max Uric Acid Monitoring System	PTC	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
June 23, 2016	K160156	StatStrip Xpress Blood Glucose Monitoring System	NBW	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
January 27, 2016	K152986	StatStrip Xpress 2 Glucose Hospital Meter System	PZI	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
September 10, 2015	K151982	Stat Profile Prime ABG Analyzer System	CHL	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
May 29, 2015	K141907	STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A	CHL	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
May 20, 2015	K150461	StatStrip Xpress Glucose Hospital Meter System	PZI	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
May 6, 2015	K150281	StatStrip Glucose Hospital Meter	PZI	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
October 17, 2014	K142220	Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)	CHL	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
September 24, 2014	K132121	STATSTRIP GLUCOSE HOSPITAL METER SYSTEM	PZI	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
March 25, 2014	K131703	NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM	CHL	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
October 17, 2013	K131013	FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
April 4, 2013	K122688	NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR	LFR	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
December 20, 2012	K122435	NOVA ONE BLOOD GLUCOSE MONITOR	LFR	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
January 5, 2012	K112955	NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM	KHP	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
August 29, 2011	K110648	NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM	CHL	Substantially Equivalent	Nova Biomedical Corporation	accessdata.fda.gov
August 17, 2011	K100602	NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS	KHP	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
August 27, 2010	K101633	NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH	JJY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 15, 2010	K091547	NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS	NBW	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
July 11, 2007	K070960	NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM	CGA	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
June 13, 2007	K070255	NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002	NBW	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
May 7, 2007	K070068	NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS	CGL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 24, 2007	K063821	NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM	CGA	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
November 1, 2006	K061830	STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+	CIG	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
April 28, 2006	K060345	NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS	CGA	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
May 19, 2004	K040603	PARADIGM LINK BLOOD GLUCOSE METER	NBW	Substantially Equivalent	Becton, Dickinson & CO	accessdata.fda.gov
May 7, 2004	K041016	NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS	JJX	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 2, 2004	K033433	NOVA GLUCOSE CONTROL SOLUTIONS	JJX	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
December 20, 2002	K023567	STAT PROFILE PHOX PLUS L ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
November 22, 2002	K022746	STAT PROFILE CRITICAL CARE XPRESS ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
July 25, 2002	K021713	STAT PROFILE PHOX PLUS C ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
June 10, 2002	K020297	STAT PROFILE CRITICAL CARE XPRESS ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
February 28, 2002	K014295	STAT PROFILE PHOX ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 15, 2002	K013729	STAT PROFILE PHOX BASIC ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
August 20, 2001	K012058	STAT PROFILE PHOX PLUS L ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
October 19, 2000	K002613	MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
April 17, 2000	K000895	STAT PROFILE PHOX PLUS ANALYZER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
December 2, 1999	K993104	STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR	GLY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
July 22, 1998	K982277	MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
April 15, 1998	K980991	NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER	CHL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
August 23, 1996	K963005	NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)	JFL	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
August 23, 1996	K962982	NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT	JJY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
August 15, 1996	K962997	NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3	JJY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
April 25, 1996	K955013	NOVA CO-OXIMETER ANALYZER	GLY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
February 2, 1996	K955264	NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2	JJY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
February 2, 1996	K955260	NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION	JJY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
February 2, 1996	K955252	NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4	JJY	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
February 8, 1995	K945584	NOVA 16 ANALYZER	JJC	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 28, 1993	K924547	NOVA 8 CRT ANALYZER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
November 6, 1992	K924864	NOVA 13 ANALYZER, MODIFICATION	CGZ	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
November 6, 1992	K924743	NOVA 12 ANALYZER, MODIFICATION	CGA	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
September 29, 1992	K923806	ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
July 17, 1992	K922215	NOVA 14 NA/K/CL/GLU/BUN ANALYZER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 27, 1992	K915178	NOVA 11 NA/K/LI ANALYZER	CEM	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 27, 1992	K915177	NOVA 5 NA/K/C1 ALALYZER	CEM	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
January 15, 1992	K915176	NOVA 4 NA/K/C1/TCO2/LI ANALYZER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
September 11, 1991	K912561	NOVA 13 ANALYZER	CGZ	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
July 17, 1991	K912560	NOVA 12 ANALYZER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov
July 1, 1991	K912559	NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER	JGS	Substantially Equivalent	Nova Biomedical Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 29, 2026	99546	Class I	Ongoing	StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.	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 disp	accessdata.fda.gov
November 20, 2024	95783	Class I	Ongoing	StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.	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 DM	accessdata.fda.gov
September 18, 2023	93095	Class II	Ongoing	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 Analyze	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.	accessdata.fda.gov
June 19, 2017	77532	Class II	Terminated	Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime	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.	accessdata.fda.gov
October 10, 2013	66398	Class II	Terminated	Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436.	Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage	accessdata.fda.gov
July 15, 2013	65617	Class I	Terminated	Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Lo	Reports of false abnormally high glucose readings from test strips	accessdata.fda.gov
February 25, 2013	64638	Class II	Terminated	Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214	Glucose test strips reports no result message when tested	accessdata.fda.gov
February 12, 2010	54630	Not yet classified	Terminated	Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitativ	Glucose strips report low glucose results	accessdata.fda.gov
August 11, 2008	49127	Not yet classified	Terminated	Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantita	Erroneous, low creatinine results on CCX analyzer	accessdata.fda.gov
February 21, 2008	46904	Not yet classified	Terminated	Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Me	Lithium batteries may fail if the glucose or creatinine meters have been dropped.	accessdata.fda.gov
November 2, 2007	45815	Not yet classified	Terminated	Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454	Incorrect Results - Creatinine results were lower than the laboratory reference method.	accessdata.fda.gov
September 17, 2007	44941	Not yet classified	Terminated	Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA	Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples	accessdata.fda.gov
January 27, 2006	34522	Not yet classified	Terminated	Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942	Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs	accessdata.fda.gov
March 30, 2004	28725	Not yet classified	Terminated	Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942	Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems	accessdata.fda.gov
September 22, 2003	27334	Not yet classified	Terminated	Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394	Degradation of the magnesium sensor could result in low ionozed magnesium patient samples	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.