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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity Laboratory Instrument Interface Software

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  Class 2 Device Recall GE Centricity Laboratory Instrument Interface Software see related information
Date Initiated by Firm August 27, 2010
Date Posted October 22, 2010
Recall Status1 Terminated 3 on July 15, 2011
Recall Number Z-0123-2011
Recall Event ID 56627
Product Classification Calculator/Data Processing Module For Clinical Use. - Product Code JQP
Product 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.
Code Information Software Version 3.3 and newer.
Recalling Firm/
Manufacturer		 Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
Manufacturer Reason
for Recall		 Instrument may incorrectly report the result of an antimicrobial sensitivity test.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 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, and Scotland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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