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Recall Observatory FDA recall evidence

Device product

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

Z-0493-2018

November 21, 2017

Class II

Product summary

Firm
Horiba Instruments, Inc dba Horiba Medical
Event
Event 78692
Status
Terminated
Classification
Class II
Quantity
10 bags, 100 units each
Official record key
device-enforcement:Z-0493-2018

Official wording

Reason: 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.

Code information: DATE - MVT 25.08.2017

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.