Recall Z-0632-2013— Horiba Instruments, Inc dba Horiba Medical

Name: FDA recall Z-0632-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-10

Class II · Terminated

Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2012-10-10, terminated 2013-09-12. It names one FDA 510(k) clearance: K060318. Product: ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.. Reason: Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm..

Recalling firm: Horiba Instruments, Inc dba Horiba Medical
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Terminated: 2013-09-12
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060318 — HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx·cleared 2006-08-08

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 AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.

Reason for recall

Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.

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