FDA Enforcement
Class II
Terminated
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Recall: Z-0639-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0639-2019
- Event ID
- 81589
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- bioMerieux, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 26, 2018
- Initiation Date
- November 13, 2018
- Classification Date
- December 19, 2018
- Termination Date
- July 7, 2021
- Address
- 100 Rodolphe St, Durham, NC, 27712-9402, United States
Description
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.
Code Info
Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260
Distribution
Nationwide distribution to CO, IL, MO, TX.
Quantity
five (5) VITEK¿ 2 Systems Software version 9.01