Device Name: ABX PENTRA ML Model/Part # — Class II medical device recall Z-1173-2014
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2014-03-19, distributed nationwide. HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a soft
| Recall number | Z-1173-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical, Irvine, CA, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Reason classes | software |
| Model numbers | A11A01652 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1173-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.