U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Customers have reported that some vitek¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. the issue was reported to occur on vitek¿ 2 compact 15 and compact 30 systems following a system software update to version 8.01.
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Consignees (Subsidiaries) of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 07/12/2017. The direct consignees (subsidiaries and distributors) have until 08/12/2017 to notify their respective impacted users.
The directions to the user are as follows:
Please implement the following actions at this time:
" Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization.
" Refrain from performing the VITEK¿ 2 Systems Software 8.01 update.
o A solution has been identified, and your local bioM¿rieux representative will contact you with further instruction in the coming weeks.
" If you have updated VITEK¿ 2 Systems Software to version 8.01 within the last seven (7) days, please contact your local bioM¿rieux representative.
" Please store this letter with your bioM¿rieux instrument documentation.
" Complete the Acknowledgement Form and return it to your local bioM¿rieux representative."
VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.