Becton Dickinson Recalls EpiCenter Plus Software Version 6.20A
Becton Dickinson is recalling EpiCenter Plus Microbiology Data Management System software version 6.20A because outdated translation tables may cause mis-identification of organisms.
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 (medical device software) where mis-identification of organisms could impact patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling EpiCenter Plus Microbiology Data Management System software version 6.20A, which is used in conjunction with the MALDI BioTyper System. The recall affects approximately 115 customers, including 15 US customers and 18 Ex-US sites.
The recall was initiated because the information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This discrepancy could lead to a possible mis-identification of an organism.
The affected software is identified by Version 6.20A and Catalog Number 442953. Users of this software should contact Becton Dickinson & Co. for further instructions on how to resolve the issue.
The recalled product
- Product
- EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter…
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 115
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)
- Lot Numbers Version 6.20A Cat. Number 442953
Distribution
Distribution scope not specified by the agency.
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