The Recall Desk

FDA (Devices) recall action 63838

Horiba Instruments, Inc dba Horiba Medical recalled 2 products on 2013-01-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-01-09
Critical
0
Units
67,270

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-01-09

    Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer

    Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.

    Product
    PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and…
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2013-01-09

    Horiba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent

    Horiba Medical is recalling ABX PENTRA AST CP reagent because it recorded incorrect low values for high AST levels without triggering an alarm.

    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.
    Category
    Distribution
    7 states