GE Centricity Laboratory System Recall for Free-Text Data Loss
GE Healthcare is recalling 5 units of the Centricity Laboratory System because free-text data from instruments may be discarded if orders are not yet in the system.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves data loss (discarded free-text) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity where the risk is significant but not immediately life-threatening or associated with reported injuries.
Plain-English summary
GE Healthcare is recalling 5 units of the Centricity Laboratory System, a software information system designed to support clinical and administrative activities in laboratory facilities. The recall covers software versions 3.3, 4.0, and 4.1. The product was distributed worldwide, including in the United States (specifically Minnesota) and internationally to India, Australia, Canada, and England.
The recall is due to a potential safety issue where free-text sent from an instrument is not transcribed into the iNET system. This occurs when an instrument uploads results to the interface before the corresponding order or request is present in the system. In these specific situations, the test-level supporting free-text is discarded and not captured.
The Centricity Laboratory System is intended for use by laboratory technologists, technicians, analysts, and other trained system users. It is not intended for direct patient contact. Users should be aware that data integrity may be compromised in the specific scenario described.
The recalled product
- Product
- 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, e.g., the storing and delivering of analytical…
- Manufacturer
- GE Healthcare It
- Hazard
- Affected units
- 5
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)
- Software Versions: 3.3
- 4.0
- 4.1
Distribution
Distributed in 1 state:
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