FDANovember 21, 2017device

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

horiba instruments inc dba horiba medicalhoribahoriba instruments

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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