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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72972

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

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Event summary

Timeline bucket
December 18, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Instrumentation Laboratory Co.

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

HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate

Z-0736-2016
Recall number
Z-0736-2016
Initiated
December 18, 2015
Classification
Class II
Status
Terminated
Quantity
Domestic: 108 kits, Foreign: 197 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This Lot is not meeting labeled on-board instrument stability claims of 5 days.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This Lot is not meeting labeled on-board instrument stability claims of 5 days.

Code information

Lot No. N0455811, Expiration Date 03/31/2017

Distribution pattern

Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.