Nov

2012

Cl ll bioMerieux BacT/ALERT 3D 60

Company: BioMerieux Inc.
Date of Enforcement Report 11/28/12
Class ll:

PRODUCT

bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin. Recall Number Z-0301-2013

REASON
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.

RECALLING FIRM/MANUFACTURER
Biomerieux Inc., Hazelwood, MO on 10/16/2012 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
145 modules

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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Cl ll bioMerieux BacT/ALERT 3D 60

Amy Sellers

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