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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66912

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

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Event summary

Timeline bucket
November 21, 2013
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

ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.

Z-0904-2014
Recall number
Z-0904-2014
Initiated
November 21, 2013
Classification
Class II
Status
Terminated
Quantity
698 units total (80 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

Code information

Lot No. 1300801

Distribution pattern

Worldwide Distribution - USA (nationwide)