FDA Medical Device Recalls (openFDA)
Ge Healthcare It: 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.
- Recall number
- Z-0123-2011
- Recalling firm
- Ge Healthcare It
- 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.
- Status
- Terminated
- Initiated
- 2010-08-27
- Posted
- 2010-10-22
- Terminated
- 2011-07-15
- Reason
- Instrument may incorrectly report the result of an antimicrobial sensitivity test.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Software Version 3.3 and newer.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3004526608
- Firm city
- Barrington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28