Horiba Instruments, Inc dba Horiba Medical recalls ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

Recall date

November 13, 2014

Source

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

Recall number

Z-0902-2015

FDA classification

Class II

Brand / firm

Horiba Instruments, Inc dba Horiba Medical

Sold / distributed

Nationwide in US

Why it was recalled

HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they 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. The defect would result in a false high or false low results for HbA1c and false high results for magnes

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

What was recalled

ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)