Duane Reade TRUEtrack monitor kit — Class II medical device recall Z-1140-2013
Terminated recall by Nipro Diagnostics, Inc., reported 2013-04-24, distributed nationwide. Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
| Recall number | Z-1140-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Diagnostics, Inc., Ft Lauderdale, FL, United States |
| Recall initiated | 2013-02-25 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,627 kits |
| UPC / GTIN / UDI-DI | 00639194016797 |
| Lot numbers | KL01009-12TI, KL01009-3TI, KL01233-4TI, KM0548TI, KM0645TI, KM0692TI, RL3435, RL3476, RM3547, RM3562 |
| Model numbers | A4006-81 |
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 for recall
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1140-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.