Class II — Horiba Instruments, Inc dba Horiba Medical
| Recalling firm | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 15 |
| Distribution | USA Nationwide Distribution |
| Initiated | 2014-02-14 |
| Classified | 2014-03-10 |
| Terminated | 2014-08-22 |
| Recall number | Z-1173-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Horiba Instruments, Inc dba Horiba Medical (Z-1173-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67528/
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