ABX PENTRA N Control — Class II medical device recall Z-0904-2014
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2014-02-12, distributed nationwide. Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target V
| Recall number | Z-0904-2014 |
|---|---|
| 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 | 2013-11-21 |
| Classified | 2014-01-31 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-10-28 |
| Distributed | Nationwide (US) |
| Lot numbers | 1300801 |
| Model numbers | A11A01653 |
Product
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Reason for recall
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
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-0904-2014. 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.