FDANovember 13, 2014device

ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

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

The hazard

HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they 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 defect would result in a false high or false low results for HbA1c and false high results for magnes

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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