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Recall Observatory FDA recall evidence

Device product

ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

Z-0902-2015

November 13, 2014

Class II

Product summary

Firm
Horiba Instruments, Inc dba Horiba Medical
Event
Event 69773
Status
Terminated
Classification
Class II
Quantity
443 units
Official record key
device-enforcement:Z-0902-2015

Official wording

Reason: 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

Code information: Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.

Distribution pattern: Nationwide in US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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