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All Recalls

Every Horiba Instruments, Inc Dba Horiba Medical Recall

Sorted by most recent. Click any recall for full details.

10 recalls
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to ...
Medical Devices·686 affected·Apr 26, 2018
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Diagnostic Devices·10 affected·Nov 21, 2017
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this corre...
Medical Devices·15 affected·Feb 14, 2014
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision ...
Medical Devices·698 affected·Nov 21, 2013
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle con...
Diagnostic Devices·2,658 affected·Sep 6, 2013
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Be...
Medical Devices·905 affected·Mar 20, 2013
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Co...
Medical Devices·180 affected·Feb 15, 2013
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Medical Devices·10 affected·Sep 20, 2012
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level co...
Diagnostic Devices·22,954 affected·Sep 14, 2012
RecallFDA
Horiba Instruments, Inc Dba Horiba Medical
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The AB...
Diagnostic Devices·8,503 affected·Sep 14, 2012