Horiba Instruments, Inc dba Horiba Medical recalls 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

Recall date

November 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0493-2018

FDA classification

Class II

Brand / firm

Horiba Instruments, Inc dba Horiba Medical

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400