Inc., Class lll Beckman Coulter

Company: Beckman Coulter, Inc.
Date of Enforcement Report:2/8/2006

a) OULTER LH 700 Series Hematology
Analyzer, PN 6605632 and 6605632R,
Recall # Z-0474-06;
b) COULTER GEN.S Series Hematology Analyzer,
PN 6605632, 6605632R; GENS: 6605381,
6605381R, 6605360, 6605360R, 6605470,
6605470R Recall # Z-0475-06

There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

All software versions

Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Beckman Coulter, Inc., Brea, CA, by letter the week of December 19, 2005. Firm initiated recall is ongoing

2,849 units

Nationwide and Canada

About the author

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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

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