CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report

Abx Pentra ML recalled by Horiba Instruments

Horiba Instruments is recalling Abx Pentra ML, distributed nationwide in the US. The recall was initiated on 14 Feb 2014 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled15

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1173-2014
FDA event ID: 67528
Recalling firm: Horiba Instruments, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2014
FDA classified: 10 Mar 2014
Reported: 19 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

14 Feb 2014	Recall initiated by company
10 Mar 2014	Classified by FDA	+24 days
19 Mar 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

USA Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

USA Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Horiba Instruments

All 28

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10 Jul 2024Device	CLASS II	Horiba custom configured fluorescence instrument recalled	Horiba Instruments	Foreign Material	Nationwide
16 Oct 2019Device	CLASS II	Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400 recalled	Horiba Instruments	Other	40 states
4 Jul 2018Device	CLASS II	ABX Pentra Micro Albumin 2 CP, Serum/Plasma recalled	Horiba Instruments	Other	Nationwide
7 Feb 2018Device	CLASS II	Reagent Cup, B1037307, Sap 1221037307 for use recalled	Horiba Instruments	Device Malfunction	Nationwide
7 Feb 2018Device	CLASS II	Reagent Cup, B1034626, Sap 1221034626 for use recalled	Horiba Instruments	Device Malfunction	Nationwide

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