Horiba Instruments, Inc dba Horiba Medical

Complete recall history across all FDA and CPSC categories — 17 total recalls

Horiba Instruments, Inc dba Horiba Medical appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by Horiba Instruments, Inc dba Horiba Medical

Date Product Reason Class
Apr 26, 2018 ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device i... When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispe... Class II
Nov 21, 2017 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PEN... The ABX PENTRA Reagent Containers do not always sit properly into the reagent... Class II
Nov 21, 2017 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PEN... The ABX PENTRA Reagent Containers do not always sit properly into the reagent... Class II
Nov 13, 2014 ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), a... HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they... Class II
Aug 11, 2014 ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX P... Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the ... Class II
Feb 14, 2014 Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... HORIBA Medical initiated this recall of all software versions of ABX PENTRA M... Class II
Jan 20, 2014 ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX... HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control... Class II
Dec 18, 2013 ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le... HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers runnin... Class III
Nov 21, 2013 ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for ... Horiba Medical is recalling the ABX PENTRA N Control because it has been upda... Class II
Sep 6, 2013 ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essentia... HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a pote... Class III
Mar 20, 2013 HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400IS... HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module cu... Class II
Feb 15, 2013 ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... Horiba Medical is recalling ABX Micros IM2 Data Management System because it ... Class III
Oct 10, 2012 PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully aut... Horiba Medical is recalling the ABX PENTRA AST CP because during the AST appl... Class II
Oct 10, 2012 ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent i... Horiba Medical is recalling the ABX PENTRA AST CP because during the AST appl... Class II
Sep 20, 2012 ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issu... Class II
Sep 14, 2012 ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N... This recall was initiated because some customers were experiencing an alarm d... Class III
Sep 14, 2012 Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Leve... HORIBA Medical Irvine Technical Support received reports from some customers ... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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