FDA Enforcement
Class II
Terminated
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.
Recall: Z-0904-2014
·
Reported February 12, 2014
Enforcement
- Recall Number
- Z-0904-2014
- Event ID
- 66912
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Horiba Instruments, Inc dba Horiba Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 12, 2014
- Initiation Date
- November 21, 2013
- Classification Date
- January 31, 2014
- Termination Date
- October 28, 2014
- Address
- 34 Bunsen, Irvine, CA, 92618-4210, United States
Description
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.
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 Info
Lot No. 1300801
Distribution
Worldwide Distribution - USA (nationwide)
Quantity
698 units total (80 units in US)