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
