Recall Z-1173-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Horiba Instruments, Inc dba Horiba Medical
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
| Date | Mar 11, 2014 (initiated Feb 14, 2014) |
| Status | Terminated |
| Reason | HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System. |
| Root cause | Software design |
| Action | Horiba sent an "URGENT SAFETY NOTICE letter datedFebruary 13, 2014 via by mail to customers. The letter identified the affected product, issue, impact, actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory documentation. Customers were requested to complete and return the enclosed response form via one of the following methods: Fax: 949-453-0600 Email: jim.knowles@horiba.com Mail: HORIBA Medical Attention: Jim Knowles, Recall Coordinator 34 Bunsen Drive Irvine, CA 92618. For questions contact yo |
| Quantity | 15 |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053308 | ABX MICROS CRP 200, OPTION IM Horiba Abx, Dec 29, 2005 |