EpiCenter Plus Microbiology Data Management System recall
EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage…
Why was EpiCenter Plus Microbiology Data Management System recalled?
The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers Version 6.20A Cat. Number 442953
- Product
- EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage…
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- Qty Distr. to Field - 115
- Distribution
- 15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
- Recall date
- March 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)