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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63410

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

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Event summary

Timeline bucket
August 06, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Diamedix Corporation

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

The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.

Z-0445-2013
Recall number
Z-0445-2013
Initiated
August 06, 2012
Classification
Class II
Status
Terminated
Recalling firm
Diamedix Corporation
Quantity
65 Test Kits

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

Code information

Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012

Distribution pattern

Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador