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 Multical. ABX PENTRA N Control. ABX PENTRA P Recalled by Horiba Instruments, Inc dba Horiba Medical Due to HORIBA Medical is informing all ABX PENTRA MultiCal,...

Date: January 20, 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 Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml.

Quantity: 2,023 units

Why Was This Recalled?

HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers

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