CLASS II Device recall · Reported 9 Jan 2013 · FDA Enforcement Report

Pentra C200 recalled by Horiba Instruments

Horiba Instruments is recalling Pentra C200, distributed nationwide in the US. The recall was initiated on 10 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: 00456-4108

Quantity recalled384 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0633-2013
FDA event ID: 63838
Recalling firm: Horiba Instruments, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2012
FDA classified: 3 Jan 2013
Reported: 9 Jan 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

10 Oct 2012	Recall initiated by company
3 Jan 2013	Classified by FDA	+85 days
9 Jan 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 uring.

Where it was distributed

Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

Nationwide Arizona California Florida New York Oklahoma Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot number: 00456-4108

Where was it sold?

Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 63838

This product is part of a recall event; the main page for the event is Abx Pentra Ast Cp recalled by Horiba Instruments.

Reported	Class	Recall	Company	Reason	Where
9 Jan 2013	CLASS II	Abx Pentra Ast Cp recalled by Horiba Instruments	Horiba Instruments	Device Malfunction	Nationwide

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