FDA-Device2014-02-12Class II
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Horiba Instruments, Inc dba Horiba Medical
Hazard
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
Sold states
Worldwide Distribution - USA (nationwide)
Affected count
698 units total (80 units in US)
Manufactured in
34 Bunsen, Irvine, CA, United States
Products
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0904-2014Don't want to check this manually?
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