BACTEC" FX System Software, catalog #441398 and #441750 The BD BACTEC" FX instrument is designed for the rapid detection

FDA device recall Z-2626-2011 · posted 2011-06-23 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.

Action taken

BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated August 2010 to all affected customers. The letter describes the product, problem and action to be taken. The letter described the type of error messages the customers may experience. All affected units will be scheduled for on site software update as well as a disk drive replacement. A BD field service engineer will contact the customers to schedule the on site visit. Customers experiencing issues prior to the scheduled visit or have questions should contact the BD Diagnostics Service Department at 800-638-8663.

Root cause

Software design

Status

Terminated

Product code

MDB

Quantity affected

907 units

Distribution

Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.

Date initiated

2010-08-10

Date posted

2011-06-23

Date terminated

2011-07-05

Location

Sparks, MD