FDAFDA · Food and drugs·Recall number Z-0639-2019
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Published December 26, 2018 · Recall initiated: November 13, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- bioMerieux, Inc.
- Distributor
- Nationwide distribution to CO, IL, MO, TX.
- Lot
- Product Description: KIT UPDT VTK2 9.01 EN, UDI: 03573026561260
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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