Horiba Instruments, Inc dba Horiba Medical recalls ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain…

Recall date

April 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2286-2018

FDA classification

Class II

Brand / firm

Horiba Instruments, Inc dba Horiba Medical

Sold / distributed

Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.