Nov

2002

Hamilton Company Class II

Company: Hamilton Company
Date of Enforcement Report: 11/13/02
Class: II

PRODUCT
a) Hamilton Brand Sunrise Software – for the Microlab AT series Instruments;
b) Hamilton Brand Sunplus Software – for the Microlab AT Plus and AT Plus 2 series Instruments; Recall # B-0115-3.

REASON
Automated pipette software, which had a glitch or defect, was distributed.

CODE
a) Versions 1.0, 2.0, 3.0, 4.0, 5.0, 5.1, 5.2, 5.3, 5.3.1, 5.3.3
b) Versions 1.0, 1.1, 2.0, 3.0, 3.1, 3.2, 3.3, 3.3.1, 3.3.2, 3.3.3.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Company, Reno, Nevada, by letter dated May 1, 2002.
Manufacturer: Hamilton Bonadux AG, Switzerland.
Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
1,158 distributed.

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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Hamilton Company Class II

Amy Sellers

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