GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The

FDA device recall Z-0123-2011 · posted 2010-10-22 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

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

Action taken

The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated August 27, 2010 to GE Centricity Laboratory software customers on the same date. The letters advised the users of the patient safety issue associated with the use of GE Centricity Laboratory instrument interface to Biomerieux's Vitek analyzer where results may be incorrectly reported. The letters provided the users with specific safety instructions to follow until the software is updated. The customers were requested to complete the enclosed customer reply form and fax the completed form to 847-620-2780. Any questions should be directed to their GE Service Representative or the GE Help desk at 888-778-3375.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

22 units

Distribution

Worldwide Distribution -- USA, including states of Georgia, Michigan, Minnesota, New York, Ohio, Oregon, Tennessee, and Texas and countries of Australia, Canada, England, India, New Zealand, Qatar, an

Date initiated

2010-08-27

Date posted

2010-10-22

Date terminated

2011-07-15

Location

Barrington, IL