Z-0639-2019Class II

VITEK 2 Systems Software Version 9.01 Update Kit

Name: Z-0639-2019 VITEK 2 Systems Software Version 9.01 Update Kit
Creator: bioMerieux, Inc.
Published: 2018-11-13
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-11-13 / Terminated / root cause: software

FDA source

bioMerieux, Inc. began a recall of VITEK 2 Systems Software Version 9.01 Update Kit on 2018-11-13. FDA classified it as Class II and gives the reason as "The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP"...". 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-0639-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-13
Posted: 2018-12-19
Terminated: 2021-07-07
Recalling firm: bioMerieux, Inc.
Product: VITEK 2 Systems Software Version 9.01 Update Kit.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP" feature.
Root cause tag: software
FDA root cause: Software design
Action: bioMerieux notified customers of the recall on about 11/13/2018 via "URGENT PRODUCT CORRECTION NOTICE." Instructions included taking the following actions: 1) Confirm the letter has been distributed to, and reviewed by, all appropriate personnel; 2) If appropriate in accordance with consignee's laboratory's Standard Operating Procedures, perform retrospective review of any patient results potentially impacted in relation to the described VITEK FLEXPREP anomaly; 3) Store this letter with the bioMrieux, Inc. VITEK 2 instrument documentation; 4) Complete and return the Acknowledgement Form in Attachment A to confirm receipt of the notice and return it to your local bioMrieux, Inc. representative. Regardless of each consignee's current use of the VITEK FLEXPREP" feature, your local Field Service Engineer has implemented the software solution on your VITEK 2 System. If you require additional assistance or have any questions, please contact your local bioMrieux, Inc. Clinical Customer Service representative at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24-48 hours during normal business hours (7AM 7PM EST), and up to 72 hours dependent upon weekends and company observed holidays.
Quantity in commerce: five (5) VITEK¿ 2 Systems Software version 9.01
Distribution: Nationwide distribution to CO, IL, MO, TX.
Product codes and lots: Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0639-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0639-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)