Company: CaridianBCT
Date of Enforcement Report 5/23/12
Class ll:
PRODUCT
Trima Accel Automated Blood Collection System, catalog number 917000000. Product Usage: Automated Blood Collection System for use in humans. Recall # Z-1541-2012
REASON
Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.
RECALLING FIRM/MANUFACTURER
CaridianBCT, Inc., Lakewood, CO, by letter dated March 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,278 machines
DISTRIBUTION
Nationwide
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