10 ML REAGENT CUP — Class II medical device recall Z-0493-2018
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2018-02-07, distributed nationwide. The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scena
| Recall number | Z-0493-2018 |
|---|---|
| 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 | 2017-11-21 |
| Classified | 2018-01-31 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
Product
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Reason for recall
The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an 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-0493-2018. 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.