Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2018 - (Recall #: Z-0494-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400

Product Classification:

Class II

Date Initiated: November 21, 2017

Date Posted: February 7, 2018

Recall Number: Z-0494-2018

Event ID: 78692

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.

Status: Terminated

Product Quantity: 10 bags of 100 units

Code Information:

DATE - MVT 25.08.2017

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated