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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 cert
Recalled July 4, 2018 · FDA recall Z-2286-2018 · Horiba Instruments, Inc
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. · FDA Class II
Units
686 devices (233 devices US, 453 devices OUS)
Sold at
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.
Description
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.
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.
Manufacturer(s)
Horiba Instruments, Inc dba Horiba Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →