Z-1554-2016 Class II Terminated
FDA device recall Z-1554-2016 was initiated by Horiba Instruments Inc on February 19, 2016 and is designated Class II. 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 alarm… The recall status is terminated (terminated August 17, 2016). Affected quantity: 201.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- February 19, 2016
- Termination Date
- August 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 201
Product Description
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 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.
Distribution Pattern
USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
Code Information
All lot/serial #s