PENTRA C200 — Class II medical device recall Z-0633-2013
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-0633-2013 |
|---|---|
| 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 | 384 units |
| Lot numbers | 00456-4108 |
| Model numbers | A11A01629 |
Product
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
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-0633-2013. 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.