Horiba ABX PENTRA 400 I.S.E. Module Recalled for Missing Linearity Flags
Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.
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, which typically corresponds to a moderate severity score. The hazard involves a software limitation that may affect the accuracy of test results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Horiba Instruments, Inc dba Horiba Medical is recalling the HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers P400ISE110EN02 and P400ISE110US02, for all serial numbers with software versions 5.0.7 and below. The recall involves 905 units that were distributed nationwide.
The recall is being issued because the I.S.E. assays programmed into the ABX PENTRA 400 Analyzer software do not have Linearity Limit Flags. These flags are designed to alert users when assay values fall below or above the validated linearity range. While other assays on the analyzer include these flags, the I.S.E. assays currently lack them, which may prevent users from identifying values outside the validated range.
Customers using the ABX PENTRA 400 Analyzer with the I.S.E. Module should contact Horiba Medical for further instructions regarding the recall and potential software updates or replacements.
The recalled product
- Product
- HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Affected units
- 905
Distribution
Distributed nationwide across the United States.
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