Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2015 - (Recall #: Z-0902-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 13, 2014

Date Posted: January 14, 2015

Recall Number: Z-0902-2015

Event ID: 69773

Reason for Recall:

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

Status: Terminated

Product Quantity: 443 units

Code Information:

Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.

Distribution Pattern:

Nationwide in US

Voluntary or Mandated:

Voluntary: Firm initiated