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.

Recall Insight

This FDA Devices action (record #Z-0904-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on November 21, 2013. 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 698 units total (80 units in US) units are affected.

The documented reason for this recall is: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide). 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 12 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.