Recall Z-2767-2011 ยท LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
VITEK 2 System, VITEK 2 60 110V (Catalog #27225) and VITEK 2 60 220V (Catalog #27226). 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
| Date | Jul 9, 2011 (initiated Jun 2, 2011) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 D |
| Quantity | 627 instruments |
| Distribution | 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, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.