Mar

2004

Beckman Coulter Inc Class II

Company: Beckman Coulter Inc
Date of Enforcement Report: 3/24/04
Class: II

PRODUCT
a) CXP software, Part No. 623560. Recall # Z-0635-04;
b) Cytomics MXP Software, Part No. 623688.
Recall # Z-036-04;
c) Cytomics RXP Software, Part Numbers: 175488, 6418489,
175260, 175261, 175262, 175263, 175264, 175265.
Recall # Z-0637-04.

REASON
Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.

CODE
a), b) and c) Version 1.0.

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, by modified operating instructions on February 13, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
418.

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 Class II

Amy Sellers

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