Oct

2007

Beckman Coulter Inc Cell Preparation System Cl II

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

About the author

Amy Sellers

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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Beckman Coulter Inc Cell Preparation System Cl II

Amy Sellers

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