# FDA recall Z-0493-2018

> **Horiba Instruments, Inc dba Horiba Medical** · Class II · device recall initiated 2017-11-21.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0493-2018
- **Recalling firm:** Horiba Instruments, Inc dba Horiba Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-21
- **Report date:** 2018-02-07
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0493-2018

## Citation

> AI Analytics. FDA recall Z-0493-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0493-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*