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.
What this means for you
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.
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