Nov

2013

HLA Fusion Software; Class II

Company: One Lambda Inc.
Date of Enforcement Report: 11/6/2013
Class lI:

PRODUCT

HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR
Recall Number B-2326-13

REASON
HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed.

RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA on 7/26/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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HLA Fusion Software; Class II

Amy Sellers

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