ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

FDA device recall Z-0645-2013 · posted 2013-01-07 · Terminated

Recall details

Recalling firm

Horiba Instruments, Inc dba Horiba Medical

Reason for recall

Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software

Action taken

.A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

10 units

Distribution

Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.

Date initiated

2012-09-20

Date posted

2013-01-07

Date terminated

2013-03-12

Location

Irvine, CA