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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66916

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

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Event summary

Timeline bucket
August 27, 2013
Product types
Device
Classifications
Class II
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

Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

Z-0572-2014
Recall number
Z-0572-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Quantity
38 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

Code information

Product Code: 800-960, Lot number: 082, Model: 10 - plate kit

Distribution pattern

USA Nationwide Distribution in the state of WA