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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68659

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

Open FDA event record

Event summary

Timeline bucket
June 20, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ITC-Nexus Dx

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

Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

Z-2088-2014
Recall number
Z-2088-2014
Initiated
June 20, 2014
Classification
Class II
Status
Terminated
Recalling firm
ITC-Nexus Dx
Quantity
US- 315 cuvettes; OUS - 2835 cuvettes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

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

Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

Code information

Lot Number A4JCA001

Distribution pattern

Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.