Sep

2004

Inc Class II Beckman Coulter

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 9/15/04
Class: II

PRODUCT
COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-1433-04.

REASON
Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and/or print an erroneous result or an incorrect dilution factor with a predilute sample result.

CODE
Software versions 1A and 1A2.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter, dated August 12, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
222 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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Inc Class II Beckman Coulter

Amy Sellers

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