FDA-Device2018-02-07Class II
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
Horiba Instruments, Inc dba Horiba Medical
Hazard
The ABX PENTRA Reagent Containers 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.
Sold states
Nationwide
Affected count
10 bags of 100 units
Manufactured in
34 Bunsen, Irvine, CA, United States
Products
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0494-2018Don't want to check this manually?
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