FDAFDA · Food and drugs·Recall number Z-0904-2014
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.
Published February 12, 2014 · Recall initiated: November 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Distributor
- Worldwide Distribution - USA (nationwide)
- Lot
- Lot No. 1300801
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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