Horiba Medical Recalls ABX PENTRA ML Software Due to Data Validation Error
Horiba Medical is recalling ABX PENTRA ML software versions V8.0.x and below, V9.0.1, and V9.0.2 because a rare data management issue may transmit incorrect patient results to the Laboratory Information System.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the transmission of incorrect patient results, which poses a risk of harm to patients through potential misdiagnosis or treatment errors, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Horiba Medical is recalling ABX PENTRA ML software, specifically versions V8.0.x and below, V9.0.1, and V9.0.2. The recall is due to a confirmed issue with the device's data management and validation system. In a rare sequence of specific events, the system may transmit an incorrect patient result to the Laboratory Information System. This incorrect result is derived from a previous run of the same patient that is stored in the ML database.
The affected units are 10 devices with Lot/Serial# PML0937. These units were distributed nationwide in the US, including the states of California, Michigan, Indiana, Florida, and Georgia. The recall depth is retail.
Healthcare facilities and consumers should contact Horiba Medical for instructions on how to address the software issue. The source text does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Affected units
- 10
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/Serial# PML0937
Distribution
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