Food, drugs, devices › Nova Biomedical Corporation
Device recall: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Nova Biomedical Corporation (Waltham, MA) initiated this device recall on 29 Jul 2026; FDA lists 5 product records under event 99546, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 12% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Nova Biomedical Corporation has 7 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nova Biomedical Corporation, Waltham, MA.
Reason for recall
"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…"
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3128-2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. | 20,616 units | Class I | Ongoing | 23 Sep 2026 |
| Z-3129-2026 | StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. | 10,941 units | Class I | Ongoing | 23 Sep 2026 |
| Z-3130-2026 | StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. | 1,858 units | Class I | Ongoing | 23 Sep 2026 |
| Z-3131-2026 | StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. | 8,939 units | Class I | Ongoing | 23 Sep 2026 |
| Z-3132-2026 | StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. | 2,044 units | Class I | Ongoing | 23 Sep 2026 |
Context
Other enforcement events for Nova Biomedical Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Nov 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati | Device | Class I | 3 |
| 18 Sep 2023 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, an | Device | Class II | 2 |
| 19 Jun 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile P | Device | Class II | 1 |
| 10 Oct 2013 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Cr | Device | Class II | 1 |
| 15 Jul 2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are | Device | Class I | 10 |
| 25 Feb 2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | Device | Class II | 2 |
All 7 events for Nova Biomedical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.