ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

Recall Insight

This FDA Devices action (record #Z-0645-2013) was formally reported on January 16, 2013, with the manufacturer initiating the action on September 20, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Horiba Instruments, Inc dba Horiba Medical is listed as the recalling firm, operating out of Irvine, CA. Federal records indicate 10 units units are affected.

The documented reason for this recall is: 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 Syst… Distribution data in the federal record shows the product reached: Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.