FDA Device recall Z-1173-2014
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction by Horiba Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1173-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-14 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Horiba Instruments |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2018-07-04 · Horiba Instruments - 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments
All Horiba Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1173-2014%22
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