EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTy
FDA device recall Z-1414-2017 · posted 2017-02-27 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- 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.
- Action taken
- Customers were initially contacted via phone calls and subsequently provided with a written communication. For questions contact BD Technical Services Department at 1-800-638-8663.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- Qty Distr. to Field - 115
- Distribution
- 15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
- Date initiated
- 2014-08-25
- Date posted
- 2017-02-27
- Date terminated
- 2017-03-08
- Location
- Sparks, MD
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