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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64499

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 25, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nipro Diagnostics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1140-2013
Recall number
Z-1140-2013
Initiated
February 25, 2013
Classification
Class II
Status
Terminated
Recalling firm
Nipro Diagnostics, Inc.
Quantity
1,627 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Environmental control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

Code information

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.

Distribution pattern

Nationwide Distribution only in NY.