VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp57

FDA device recall Z-0989-2013 · posted 2013-03-25 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.

Action taken

bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" dated February 20, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Emails were issued by the recalling firm on 2/18/2013 and 2/19/2013 to their subsidiaries and to distributors. Letters began issuing to customers via e-mail on 2/20/2013. Contact bioMerieux Clinical Customer Service at (800) 682-2666 for questions regarding this notice.

Root cause

Software design

Status

Terminated

Product code

LTW

Quantity affected

For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina

Date initiated

2013-02-18

Date posted

2013-03-25

Date terminated

2014-08-14

Location

Hazelwood, MO