BacT/ALERT, Class II bioMerieux

Company:bioMerieux, Inc.,
Date of Enforcement Report:5/9/2007
Class:ll

PRODUCT
a) BacT/ALERT Classic System Software, Blood Culturing System,
Recall # Z-0773-2007;
b) BacT/ALERT 3D System Software, Blood Culturing System,
Recall # Z-0774-2007;
c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System,
Recall # Z-0775-2007;
d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System,
Recall # Z-0776-2007

REASON
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems

CODE
All Models

RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on/about October 18, 2006 and October 31, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10,790 units

DISTRIBUTION
Nationwide and Internationally

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.