FDA Device recall Z-1140-2013
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative… by Nipro Diagnostics, citing meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1140-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-25 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nipro Diagnostics |
| Distribution | US |
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.
Identifiers
| upc | 639194016797 |
|---|---|
| code_info | Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Str…Finished Good (FG) Kit Lot# KL01009-3TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01009-12TI, TRUEtrack Test Strip Lot# RL3435; FG Kit Lot# KL01233-4TI, TRUEtrack Test Strip Lot# RL3476; FG Kit Lot# KM0548TI, TRUEtrack Test Strip Lot# RM3547; FG Kit Lot# KM0645TI, TRUEtrack Test Strip Lot# RM3562; FG Lot# KM0692TI, TRUEtrack Test Strip Lot# RM3562. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1140-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.