Horiba Medical Recalls ABX PENTRA N Control for Revised Potassium Values
Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a revision to quality control target values rather than a direct physical injury or acute health threat, fitting the criteria for moderate severity involving minor labeling or specification errors.
Plain-English summary
Horiba Medical is recalling the ABX PENTRA N Control, Model No. A11A01653. This product is used for quality control by monitoring the accuracy and precision of quantitative methods. The recall is being conducted because the product has been updated to include a revised Target Value assignment for Potassium.
The recall involves 698 units total, with 80 units distributed in the United States. The affected units are identified by Lot No. 1300801. The product was distributed worldwide, including nationwide distribution in the USA.
Consumers and healthcare facilities should stop using the affected ABX PENTRA N Control units and contact Horiba Medical for further instructions regarding the recall.
The recalled product
- 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.
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 1300801
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Horiba Instruments, Inc dba Horiba Medical
See all →- ModerateHoriba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation
FDA (Devices) · 2018-07-04
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues
FDA (Devices) · 2015-01-14
- ModerateHoriba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update
FDA (Devices) · 2014-10-01
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateHoriba Medical Recalls ABX PENTRA Calibrators Due to Updated Target Values
FDA (Devices) · 2014-03-12
- LowHoriba Medical Recalls ABX PENTRA Urine Control L/H for Creatinine Range Update
FDA (Devices) · 2014-02-12
- ModerateHoriba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update
FDA (Devices) · 2014-10-01
- ModerateHoriba Medical Recalls ABX PENTRA Calcium CP Reagent for Incorrect Results
FDA (Devices) · 2013-10-02
- HighHoriba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent
FDA (Devices) · 2013-01-09
- HighHoriba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues
FDA (Devices) · 2015-01-14