Data Innovations Recalls JResultNet Software Due to Patient Data Mismatch Risk
Data Innovations, LLC is recalling JResultNet software because a defect may cause one patient's test results to be associated with another patient.
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 risk-of-harm product (clinical software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Data Innovations, LLC is recalling JResultNet drivers using ASTM coding language. This stand-alone software package is used for clinical data processing and provides connectivity between in-vitro diagnostic instruments and laboratory information systems. The recall covers 657 units that were distributed nationwide to 48 states and the District of Columbia.
The recall was initiated because of a software issue that could result in the results of one patient being associated with another patient. This defect affects all drive versions of the software.
Healthcare facilities and laboratories that use this software should contact Data Innovations, LLC for further instructions on how to resolve the issue.
The recalled product
- Product
- JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information…
- Manufacturer
- Data Innovations, LLC
- Affected units
- 657
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 (1)
- All drive versions were affected.
Distribution
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