Recalls / —
—#100767
Product
VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.
- FDA product code
- LTW — Susceptibility Test Cards, Antimicrobial
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- VTK2XL2129 and VTK2XL3250
Why it was recalled
Cards may not load into the incubator correctly causing them to be loaded in the wrong order which could result in the results being linked to the wrong accession number and reporting results erroneously.
Root cause (FDA determination)
Device Design
Action the firm took
Biomerieux, Inc. sent an "URGENT PRODUCT CORRECTION NOTICE" dated June 2, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers. The letter explains how to recognize the issue and instructs customers to take certain steps to resolve the problem. Additionally, an Acknowledgement Form is attached to the letter for customers to complete and return via fax to 919-314-4539. A firmware update will be applied by Biomerieux, Inc. technical support representatives. Questions regarding this recall are directed to the Customer Service Department at 1-800-682-2666, option 3.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042
Distribution
- Distribution pattern
- Worldwide Distribution-- USA (nationwide) and the countries of Austria, Australia, Belgium, Brazil, Canada, China, Colombia, Germany, France, India, Israel, Italy, Japan, Korea, Mexico, The Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Arab Emirate, and United Kingdom.
Timeline
- Recall initiated
- 2011-06-02
- Posted by FDA
- 2011-07-09
- Terminated
- 2013-06-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #100767. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.