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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Horiba Instruments Inc
- 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
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.
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