May

2007

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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BacT/ALERT, Class II bioMerieux

Amy Sellers

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