ABX PENTRA AST CP — Class II medical device recall Z-0632-2013
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2013-01-09, distributed nationwide. Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra
| Recall number | Z-0632-2013 |
|---|---|
| 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 | 2012-10-10 |
| Classified | 2013-01-03 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2013-09-12 |
| Distributed | Nationwide (US) |
| Quantity | 66,886 units |
| Lot numbers | 00456-4108 |
| Model numbers | A11A01629 |
Product
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
Reason for recall
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
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-0632-2013. 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.