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.
