FDAApril 26, 2018device

ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

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

The hazard

When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.

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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