GE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors
GE Healthcare is recalling Centricity Laboratory software versions 3.3 to 4.1 because deleting a slave panel incorrectly removes free-text notes and reference ranges from the master panel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that results in the loss of clinical data and missing reference ranges, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare is recalling 17 units of the Centricity Laboratory Core Lab System software, including versions 4.1, 4.0, 3.3.2, and 3.3Almp. The software is an information system designed to support clinical and administrative activities associated with clinical laboratory services, such as storing and delivering analytical results.
The recall is due to a software defect where deleting a slave panel automatically deletes the corresponding test results and free-text notes on the master panel. Additionally, when using the large_num.g >7 setting to report numeric results, the system fails to display appropriate abnormal flag values or reference range values in both the interface and HL7 results.
The affected software was distributed worldwide, including in the United States (GA, OH, NY, TX, TN, MN) and internationally to India, Australia, Canada, England, Qatar, and Scotland. Users of the affected software should contact GE Healthcare for instructions on how to resolve the data integrity issues.
The recalled product
- Product
- Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities…
- Manufacturer
- GE Healthcare It
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Versions 4.1
- 4.0
- 3.3.2 & 3.3Almp
Distribution
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