Recall Z-1553-2016— Horiba Instruments Inc
Class II · Terminated
Class II FDA medical device recall by Horiba Instruments Inc, initiated 2016-02-19, terminated 2016-08-17. FDA's recall record names no specific 510(k) clearance for this event. 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 measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.. Reason: Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system..
- Recalling firm
- Horiba Instruments Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-19
- Terminated
- 2016-08-17
- Firm location
- Irvine, CA, United States
Product description
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 measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Reason for recall
Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.