Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ABX PENTRA Reagent Container Recalled by Horiba Instruments, Inc dba Horiba Medical Due to HORIBA Medical is recalling the ABX PENTRA 400...

Date: November 13, 2014
Company: Horiba Instruments, Inc dba Horiba Medical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Horiba Instruments, Inc dba Horiba Medical directly.

Affected Products

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

Quantity: 443 units

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Horiba Instruments, Inc dba Horiba Medical

Horiba Instruments, Inc dba Horiba Medical has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report