Sep

2005

Beckman Coulter Inc Class II

Company: Beckman Coulter, Inc
Date of Enforcement Report:9/7/05
Class:II

PRODUCT
Aqueduct Hematology Workflow Manager, software, Part Number AQDCT, Recall # Z-1440-05

REASON
Potential for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. This may cause test results to be associated with the wrong patient.

CODE
Not specified

RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter August 8, 2005.
Manufacturer: Orchard Software Corp, Carmel, IN. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
36 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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Beckman Coulter Inc Class II

Amy Sellers

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