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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79181

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

Open FDA event record

Event summary

Timeline bucket
November 10, 2017
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Wiener Laboratories

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

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Z-0924-2018
Recall number
Z-0924-2018
Initiated
November 10, 2017
Classification
Class II
Status
Ongoing
Recalling firm
Wiener Laboratories
Quantity
1,563 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal program testing shows that product may not reach the indicated expiration date.

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

Internal program testing shows that product may not reach the indicated expiration date.

Code information

Product Code 1293254, Lot Code 1709228140

Distribution pattern

Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.