Recall Z-1554-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Horiba Instruments Inc
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.
| Date | Feb 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | HORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part |
| Quantity | 201 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.