Mar

2007

Coulter LH700 Series Hematology Analyzers Class II

Company:Beckman Coulter, Inc.
Date of Enforcement Report:3/14/2007
Class:ll

PRODUCT
Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), Recall # Z-0566-2007

REASON
There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.

CODE
2B Software (2B3, 2B4 and 2B5)

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA., by letter on September 12, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1987 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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Coulter LH700 Series Hematology Analyzers Class II

Amy Sellers

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