ABX Pentra ML recall: Software Issue
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Why was ABX Pentra ML recalled?
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Serial# PML0937
- Product
- ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 10 units
- Distribution
- Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
- Recall date
- January 16, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)