Recall Z-0639-2019— bioMerieux, Inc.

Name: FDA recall Z-0639-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-13

Class II · Terminated

Class II FDA medical device recall by bioMerieux, Inc., initiated 2018-11-13, terminated 2021-07-07. It names one FDA 510(k) clearance: K050002. Product: VITEK¿ 2 Systems Software Version 9.01 Update Kit.. Reason: 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..

Recalling firm: bioMerieux, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-11-13
Terminated: 2021-07-07
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K050002 — VITEK 2 COMPACTbioMerieux, Inc.·cleared 2005-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.