Z-3075-2017Class II

VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification...

Name: Z-3075-2017 VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification...
Creator: Biomerieux Inc
Published: 2017-07-12
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-07-12 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing... on 2017-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3075-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-12
Posted: 2017-08-25
Terminated: 2020-12-16
Recalling firm: bioMerieux, Inc.
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.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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.
Root cause tag: software
FDA root cause: Other
Action: Consignees (Subsidiaries) of bioMrieux, 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 bioMrieux 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 bioMrieux representative. " Please store this letter with your bioMrieux instrument documentation. " Complete the Acknowledgement Form and return it to your local bioMrieux representative."
Quantity in commerce: 1866 units
Distribution: Worldwide
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3075-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3075-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25
Z-3076-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25

Product code LON

K050002Class IIVitek 2 CompactbioMerieux, Inc. / cleared 2005-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)