Nipro Diagnostics, Inc.
FDA adverse event reports naming Nipro Diagnostics, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: NIPRO DIAGNOSTICS, INC..
- Total reports
- 3,979
- Deaths
- 8
- Injuries
- 3
- Malfunctions
- 3,955
Reports per year
Source: FDA adverse event reports by year received, 2010–2017. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2014-02-03TerminatedSoftware design (manufacturing process)
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
Manufactured with an incorrect factory set unit of measure.
- 2014-02-03TerminatedSoftware design (manufacturing process)
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
Manufactured with an incorrect factory set unit of measure.
- 2013-04-18TerminatedEnvironmental control
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
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