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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74932

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

Open FDA event record

Event summary

Timeline bucket
July 11, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Clark Laboratories, Inc. (dba,Trinity Biotech USA)

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

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Z-2782-2016
Recall number
Z-2782-2016
Initiated
July 11, 2016
Classification
Class III
Status
Terminated
Quantity
US: 6 kits, Foreign: 50 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

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

The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

Code information

Lot Number 2326060-043, Expiration Date 31 May 2017

Distribution pattern

Distribution to US nationwide including California, and China (Hong Kong).