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Horiba Instruments, Inc dba Horiba Medical

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 ( recall (Z-0902-2015)Horiba Instruments, Inc dba Horiba Medical2015-01-02
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium R recall (Z-2692-2014)Horiba Instruments, Inc dba Horiba Medical2014-09-24
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Versio recall (Z-1173-2014)Horiba Instruments, Inc dba Horiba Medical2014-03-11
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC recall (Z-1146-2014)Horiba Instruments, Inc dba Horiba Medical2014-03-05
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and Hig recall (Z-0924-2014)Horiba Instruments, Inc dba Horiba Medical2014-02-03
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality c recall (Z-0904-2014)Horiba Instruments, Inc dba Horiba Medical2014-01-31
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many c recall (Z-2280-2013)Horiba Instruments, Inc dba Horiba Medical2013-09-26
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All recall (Z-1141-2013)Horiba Instruments, Inc dba Horiba Medical2013-04-18
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists recall (Z-1050-2013)Horiba Instruments, Inc dba Horiba Medical2013-04-03
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 recall (Z-0645-2013)Horiba Instruments, Inc dba Horiba Medical2013-01-07
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic r recall (Z-0632-2013)Horiba Instruments, Inc dba Horiba Medical2013-01-03
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry recall (Z-0633-2013)Horiba Instruments, Inc dba Horiba Medical2013-01-03
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Norm recall (Z-0429-2013)Horiba Instruments, Inc dba Horiba Medical2012-11-21
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 20327 recall (Z-0289-2013)Horiba Instruments, Inc dba Horiba Medical2012-11-14

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Every clearance here is in the API, with alerts when new ones post.