ABX PENTRA ML — Class II medical device recall Z-0645-2013
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2013-01-16, distributed nationwide. Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data man
| Recall number | Z-0645-2013 |
|---|---|
| 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 | 2012-09-20 |
| Classified | 2013-01-07 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2013-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 10 units |
| Reason classes | software |
| Serial numbers | PML0937 |
Product
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Reason for recall
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
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-0645-2013. 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.