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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67528

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

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Event summary

Timeline bucket
February 14, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Horiba Instruments, Inc dba Horiba Medical

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

Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

Z-1173-2014
Recall number
Z-1173-2014
Initiated
February 14, 2014
Classification
Class II
Status
Terminated
Quantity
15

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug with the potential of transmitting incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.

Code information

Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A

Distribution pattern

USA Nationwide Distribution