GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. 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.
- Company
- Ge Healthcare It
- Recall Initiated
- August 27, 2010
- Posted
- October 22, 2010
- Terminated
- July 15, 2011
- Recall Number
- Z-0123-2011
- Quantity
- 22 units
- Firm Location
- Barrington, IL
Reason for Recall
Instrument may incorrectly report the result of an antimicrobial sensitivity test.
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, and Scotland.
Lot / Code Info
Software Version 3.3 and newer.
Root Cause
Software design
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.