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Horiba Instruments, Inc dba Horiba Medical recalls ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Recalled January 14, 2015 · FDA recall Z-0902-2015 · Horiba Instruments, Inc
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 · FDA Class II
Units
443 units
Sold at
Nationwide in US
Description
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
Product
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Manufacturer(s)
Horiba Instruments, Inc dba Horiba Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →