StatSensor StatStrip Gen 2.0

• FDA 510(k) K232075 decided 23 Feb 2024 Active
• FDA GUDID UDI-DI 00385480667685 listed 6 May 2026 Listed

• 2 recalls, same reason

  • Ongoing Z-3128-2026 FDA Class I ·initiated 29 Jul 2026
  • Ongoing Z-3129-2026 FDA Class I ·initiated 29 Jul 2026

  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.

• • Ongoing Z-0681-2025 FDA Class I ·initiated 20 Nov 2024

  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 DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.

1. 23 Feb 2024 Cleared FDA 510(k) K232075
2. 20 Nov 2024 Recall initiated FDA recalls Z-0681-2025
3. 6 May 2026 Listed FDA GUDID 00385480667685
4. 29 Jul 2026 Recall initiated FDA recalls Z-3128-2026
5. 29 Jul 2026 Recall initiated FDA recalls Z-3129-2026

Trade name

StatSensor StatStrip

Generic name

Glucose monitoring system IVD, point-of-care

Model / Ref / Catalog

Gen 2.0, 66768

Primary DI / UDI-DI

00385480667685

510(k) Number

K232075 ↗

FDA product code

PZI

GMDN term

Glucose monitoring system IVD, point-of-care

Device class

Class II

Regulation number

862.1345

GUDID distribution status

In Commercial Distribution

Other devices filed under FDA product code PZI (Prescription use blood glucose meter for near-patient testing).

• cobas pulse blood glucose monitoring system by Roche Diagnostics Corp.
• Assure Titanium Blood Glucose Monitoring System by Arkray, Inc.
• XPER Technology Premium Pro Blood Glucose Monitoring System by TAIDOC TECHNOLOGY CORPORATION
• StatStrip Xpress Glucose Hospital Meter System by NOVA BIOMEDICAL CORPORATION
• StatStrip Xpress 2 Glucose Hospital Meter System by NOVA BIOMEDICAL CORPORATION

• StatSensor StatStrip Gen 2.0 Open recall

  Class II

  FDA 510(k) K232075 Active Cleared 23 Feb 2024 GUDID on market

• StatSensor StatStrip Geen 2.0 Open recall

  Class II

  FDA 510(k) K232075 Active Cleared 23 Feb 2024 GUDID on market

• Stat Profile Phox Ultra/Ccx

  Class I

  FDA 510(k) K110648 Active Cleared 29 Aug 2011 GUDID on market

• Stat Profile Phox Plus L

  Class II

  FDA 510(k) K023567 Active Cleared 20 Dec 2002 GUDID on market

See all devices from Nova Biomedical Corporation →