The Recall Desk
HighFDA (Devices)·Z-0632-2013·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a diagnostic reagent that produces inaccurate results without alarm, posing a risk of harm through misdiagnosis, but no injuries or illnesses have been reported.

Plain-English summary

Horiba Medical is recalling the ABX PENTRA AST CP diagnostic reagent, Part Number A11A01629. This product is used for the quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. The recall involves 66,886 units distributed nationwide, including California, Oklahoma, New York, Florida, Arizona, Virginia, and Texas. The specific lot number is 00456-4108.

The recall was initiated because during 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. This indicates a potential for inaccurate diagnostic results where high AST levels are reported as significantly lower values.

Healthcare facilities and laboratories that possess this specific lot of the reagent should stop using it and contact Horiba Medical for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

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.
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
Category
Medical Device — Diagnostic Reagent
Hazard
Affected units
66,886

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number: 00456-4108

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Horiba Instruments, Inc dba Horiba Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Horiba Instruments, Inc dba Horiba Medical

See all →

Same hazard · inaccurate diagnostic result

See all →