StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Summary
The FDA issued a Class I for StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. by Nova Biomedical Corporation. Reason: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain .
Details
Source
Device Recall
External ID
Z-3132-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Lot/Code Info: Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
Quantity Affected: 2,044 units
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 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.
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, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Waltham, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Nova Biomedical Corporation has 17 FDA actions in our database, including 10 recalls and 7 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nova Biomedical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nova Biomedical Corporation have FDA actions?
Nova Biomedical Corporation has 17 FDA actions in our database, including 10 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3132-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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