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 is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software |
| Product | ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 |
| Quantity | 10 units |
| Distribution | Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail. |
| Initiated | 2012-09-20 |
| Classified | 2013-01-07 |
| Terminated | 2013-03-12 |
| Recall number | Z-0645-2013 |
| 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-0645-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63829/
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