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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73949

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

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Event summary

Timeline bucket
April 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Accriva Diagnostics Inc., dba ITC, dba Accumetrics

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

Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

Z-1720-2016
Recall number
Z-1720-2016
Initiated
April 22, 2016
Classification
Class II
Status
Terminated
Quantity
135 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

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Inspect official wording and provenance

Reason for recall

Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

Code information

Lot #B6JCA012

Distribution pattern

U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.