Company: Beckman Coulter Incl,
Date of Enforcement Report:10/24/2007
Class:ll
PRODUCT
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008
REASON
Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on February 22, 2007,
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide and Canada
