Recall Z-0904-2014— Horiba Instruments, Inc dba Horiba Medical

Name: FDA recall Z-0904-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-21

Class II · Terminated

Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2013-11-21, terminated 2014-10-28. It names one FDA 510(k) clearance: K052007. Product: ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.. Reason: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium..

Recalling firm: Horiba Instruments, Inc dba Horiba Medical
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Terminated: 2014-10-28
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 N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.

Reason for recall

Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

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