Recall Z-1140-2013— Nipro Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Nipro Diagnostics, Inc., initiated 2013-02-25, terminated 2013-07-08. It names 2 FDA 510(k) clearances: K032657, K030703. Product: 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.. Reason: Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range..
- Recalling firm
- Nipro Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-25
- Terminated
- 2013-07-08
- Firm location
- Ft Lauderdale, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K032657 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
- K030703 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Data sourced from openFDA. This site is unofficial and independent of the FDA.