Facility

NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS

7 recall(s) on record — most severe on record: Class I.

Key facts

7recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004193489
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	39 Manning Rd Billerica, MA, US 01821
Registration status	Active · expires 2026
Parent company	NOVA BIOMEDICAL CORP. (owner-operator 1219029)
Brand names	True Focus Pro; Focus Pro; Focus

Activity by year

Recalls (7)

Devices registered here (3)

Glucose Dehydrogenase, Glucose
Product code LFR (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
System, Test, Blood Glucose, Over The Counter
Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660

Recalls & enforcement

Class IOngoing2026-07-29
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…
Class IOngoing2024-11-20
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 …
Class IIOngoing2023-09-18
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 …
Class IITerminated2017-06-19
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.
Class IITerminated2013-10-10
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Class ITerminated2013-07-15
Reports of false abnormally high glucose readings from test strips
Class IITerminated2013-02-25
Glucose test strips reports no result message when tested

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS (FEI 3004193489) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004193489-nova-biomedical-corporation-diabetes-pro/

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