FDA-Device2015-01-14Class II
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Horiba Instruments, Inc dba Horiba Medical
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
Sold states
Nationwide in US
Affected count
443 units
Manufactured in
34 Bunsen, N/A, Irvine, CA, United States
Products
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0902-2015Don't want to check this manually?
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