28
Mar
2007

Inc. Class II bioMerieux

0

Company:bioMerieux, Inc.,
Date of Enforcement Report:3/28/2007
Class:ll

PRODUCT
BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007

REASON
Bottle data is not sent to BacT/ALERT 3D instrument.

CODE
All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).

RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on December 20, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1233 disks

DISTRIBUTION
Nationwide and Internationally

About the author

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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