Nova Biomedical recall: StatStrip Glucose Hospital Meter System and 1 more product
Nova Biomedical Corporation is recalling StatStrip Glucose Hospital Meter System and 1 more product – 20,616 units; 10,941 units; 1,858 units; 8,939 units; 2,044 units. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 29, 2026. Distributed nationwide.
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | StatStrip Glucose Hospital Meter System and 1 more product |
| Brand | Nova Biomedical |
| Company | Nova Biomedical Corporation |
| Type | Medical devices |
| Classification | Class I |
| Recall date | July 29, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 20,616 units; 10,941 units; 1,858 units; 8,939 units; 2,044 units |
| Recall ID | 99546 |
Recalled products (5)
- StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
- FDA recall number
- Z-3128-2026
- Codes, lots and dates
- Model No: 63685. UDI-DI: 00385480636858. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- Quantity
- 20,616 units
- Classification
- Class I
- StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
- FDA recall number
- Z-3129-2026
- Codes, lots and dates
- Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- Quantity
- 10,941 units
- Classification
- Class I
- StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
- FDA recall number
- Z-3130-2026
- Codes, lots and dates
- Model No: 63683. UDI-DI: 00385480636834. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- Quantity
- 1,858 units
- Classification
- Class I
- StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
- FDA recall number
- Z-3131-2026
- Codes, lots and dates
- Model No: 63910. UDI-DI: 00385480639101. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- Quantity
- 8,939 units
- Classification
- Class I
- StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
- FDA recall number
- Z-3132-2026
- Codes, lots and dates
- Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- Quantity
- 2,044 units
- Classification
- Class I
Identifiers and details
- FDA event ID
- 99546
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Waltham, MA, United States
Why it was recalled
The reason the FDA lists: “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 test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99546, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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About this recall
Is Nova Biomedical StatStrip Glucose Hospital Meter System recalled?
Yes. Nova Biomedical Corporation recalled it on July 29, 2026; FDA published it September 23, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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 test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.