Cl ll GE Centricity Instrument Interface SW

Company: GE Healthcare IT
Date of Enforcement Report 12/1/2010
Class ll:

PRODUCT
GE Centricity Laboratory Instrument Interface software. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-0123-2011

REASON
Instrument may incorrectly report the result of an antimicrobial sensitivity test.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare IT, Barrington, IL, by letters dated August 27, 2010.
Manufacturer: Triple G Systems Group, Inc., Markham Ontario, Canada. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
22 units

DISTRIBUTION
GA, MI, MN, NY, OH, OR, TN, TX, Australia, Canada, England, India, New Zealand, Qatar, and Scotland

About the author

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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