medical Class II Updated 2018-07-04

Horiba Instruments, Inc dba Horiba Medical recalls ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
View official government recall

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