Recall Z-0493-2018— Horiba Instruments, Inc dba Horiba Medical

Name: FDA recall Z-0493-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-21

Class II · Terminated

Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2017-11-21, terminated 2019-11-04. It names one FDA 510(k) clearance: K052007. Product: 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400. 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..

Recalling firm: Horiba Instruments, Inc dba Horiba Medical
Classification: Class II
Status: Terminated
Initiated: 2017-11-21
Terminated: 2019-11-04
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K052007 — ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)Horiba Abx·cleared 2005-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.