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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 Compact 15

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  Class 2 Device Recall VITEK 2 Compact 15 see related information
Date Initiated by Firm July 12, 2017
Create Date August 25, 2017
Recall Status1 Terminated 3 on December 16, 2020
Recall Number Z-3075-2017
Recall Event ID 77799
510(K)Number K050002  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Code Information 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.
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact
314-731-8526
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action 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."
Quantity in Commerce 1866 units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LON and Original Applicant = BIOMERIEUX, INC.
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