Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
FDA adverse event reports and recall history for method, enzymatic, glucose (urinary, non-quantitative) (product code JIL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 545
- Deaths
- 0
- Injuries
- 15
- Malfunctions
- 462
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-01Open, ClassifiedNo Marketing Application
Diabetes Test (ketones & glucose)
Distribution without premarket approval/clearance.
- 2024-05-16Open, ClassifiedUnder Investigation by firm
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative. The following HSI item number and lot number were affected: Urispec 11-Way, #102-2285, LOT 65402.
- 2014-10-17TerminatedProcess control
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
- 2014-10-17TerminatedProcess control
External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
- 2014-10-17TerminatedProcess control
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
- TerminatedDevice Design
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
- TerminatedNonconforming Material/Component
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
Monitor method, enzymatic, glucose (urinary, non-quantitative) automatically
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