Exact FDA event identifier

Event 67237

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

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Event summary

Timeline bucket: December 19, 2013
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. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

Z-0937-2014

Recall number: Z-0937-2014
Initiated: December 19, 2013
Classification: Class II
Status: Terminated
Recalling firm: ITC-Nexus Dx
Quantity: 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

Code information

E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.