Z-0904-2014 Class II Terminated
FDA device recall Z-0904-2014 was initiated by Horiba Instruments, Inc dba Horiba Medical on November 21, 2013 and is designated Class II. Reason for recall: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. The recall status is terminated (terminated October 28, 2014). Affected quantity: 698 units total (80 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2014
- Initiation Date
- November 21, 2013
- Termination Date
- October 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 698 units total (80 units in US)
Product 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 for Recall
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
Distribution Pattern
Worldwide Distribution - USA (nationwide)
Code Information
Lot No. 1300801