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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71493

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

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Event summary

Timeline bucket
February 10, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Tosoh Bioscience, 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

G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.

Z-2066-2015
Recall number
Z-2066-2015
Initiated
February 10, 2015
Classification
Class III
Status
Terminated
Recalling firm
Tosoh Bioscience, Inc.
Quantity
9 boxes/5 pouches

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.

Code information

Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015

Distribution pattern

Us Nationwide Distribution in the state ID including PR.