12
Jan
2005

Inc Class II Dade Behring

0

Company: Dade Behring, Inc
Date of Enforcement Report: 1/12/05
Class: II

PRODUCT
StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05.

REASON
Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.

CODE
Software version 3.5.

RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letters dated November 12, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
15 units.

DISTRIBUTION
IL, MD, NJ, OH, VA, Italy, Spain, and Portugal.

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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