CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report
ABX Pentra N Control recalled by Horiba Instruments
Horiba Instruments is recalling ABX Pentra N Control, distributed nationwide in the US. The recall was initiated on 21 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0904-2014
- FDA event ID
- 66912
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2013
- FDA classified
- 31 Jan 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 21 Nov 2013 | Recall initiated by company | |
| 31 Jan 2014 | Classified by FDA | +71 days |
| 12 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide)
Stores named: Target
Questions about this recall
Why was it recalled?
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
Which lots are affected?
Lot No. 1300801
Where was it sold?
Worldwide Distribution - USA (nationwide)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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