Recall Z-0902-2015— Horiba Instruments, Inc dba Horiba Medical

Name: FDA recall Z-0902-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-13

Class II · Terminated

Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2014-11-13, terminated 2015-03-19. It names one FDA 510(k) clearance: K052007. Product: ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL). 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.

Recalling firm: Horiba Instruments, Inc dba Horiba Medical
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Terminated: 2015-03-19
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

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

Reason for recall

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

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