Device product

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.

Z-0904-2014

November 21, 2013

Class II

Product summary

Firm: Horiba Instruments, Inc dba Horiba Medical
Event: Event 66912
Status: Terminated
Classification: Class II
Quantity: 698 units total (80 units in US)
Official record key: device-enforcement:Z-0904-2014

Official wording

Reason: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

Code information: Lot No. 1300801

Distribution pattern: Worldwide Distribution - USA (nationwide)

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.