The Recall Desk
HighFDA (Devices)·Z-1553-2016·Announced 2016-05-04

Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

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 is classified as FDA Class II, and the hazard involves a malfunction in a clinical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Horiba Instruments, Inc. is recalling ABX Pentra 400 (version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) clinical chemistry analyzers. The recall is due to malfunctions that occur when certain alarms appear on the system.

The affected devices are discrete photometric bench top chemistry analyzers intended for clinical use to measure various analytes. The recall covers 201 units distributed nationwide to the following states: CA, NY, AL, OK, MS, MD, NV, MN, TX, KY, WV, MI, MT, IL, FL, WA, ID, MO, WY, NJ, VA, GA, PA, TN, KS, AZ, NE, SC, OR, OH, IA, RI, and NC.

The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any injuries or illnesses associated with the malfunction.

The recalled product

Product
ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and meas
Manufacturer
Horiba Instruments Inc
Category
Medical Device — Clinical Chemistry Analyzer
Hazard
Affected units
201

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)

  • All lot/serial #s

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Horiba Instruments Inc 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 →

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