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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65084

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

Open FDA event record

Event summary

Timeline bucket
April 30, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wako Life Sciences, 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

uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.

Z-1831-2013
Recall number
Z-1831-2013
Initiated
April 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
Wako Life Sciences, Inc.
Quantity
36 cartridges -100 tests per cartridge

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product fails to meet the accuracy at the low end of the measuring range.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product fails to meet the accuracy at the low end of the measuring range.

Code information

TG340, Exp. 11/30/13

Distribution pattern

Distribution to CA, GA, MN, NC, UT and the District of Columbia.