FDA (Devices) recall action 78692
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
The agency’s own wording, quoted from the enforcement report.
Horiba Medical is recalling ABX PENTRA reagent cups that may not sit properly in the rack, potentially causing incorrect test results without an alarm.
Horiba Medical is recalling 15 mL reagent cups for ABX PENTRA analyzers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.