The Recall Desk
HighFDA (Devices)·Z-1554-2016·Announced 2016-05-04

Horiba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers

Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers due to malfunctions triggered by specific system alarms.

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 medical 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 voluntarily recalling the ABX Pentra 400 (version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) clinical chemistry analyzers. These devices are discrete photometric bench-top analyzers intended for clinical use to measure various analytes.

The recall is being conducted because the analyzers may malfunction when certain alarms appear on the system. The source text does not specify the nature of the malfunctions or the specific alarms involved.

The recall affects 201 units distributed nationwide in the United States to the states of 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. All lot and serial numbers are included in this recall. Users should contact Horiba Instruments for further instructions on how to proceed.

The recalled product

Product
Pentra C400 (version 1.1.2 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 measuri
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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