Jan

2007

Inc, Class II Beckman Coulter

Company:Beckman Coulter, Inc.
Date of Enforcement Report:1/10/2007
Class:ll

PRODUCT
Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers, Recall # Z-0471-2007

REASON
The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.

CODE
Version 1.1C

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on November 1, 2006.
Manufacturer: Applied Cytometry, Sheffied, UK. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide

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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Inc, Class II Beckman Coulter

Amy Sellers

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