Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2014 - (Recall #: Z-2692-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).

Product Classification:

Class II

Date Initiated: August 11, 2014

Date Posted: October 1, 2014

Recall Number: Z-2692-2014

Event ID: 69105

Reason for Recall:

Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.

Status: Terminated

Product Quantity: 359 units

Code Information:

All Lots

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated