Z-3134-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2017
- Initiation Date
- August 25, 2017
- Termination Date
- November 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,703 cartons
Product Description
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 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 VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
Reason for Recall
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC¿ 700327(TM) strain is positive.
Distribution Pattern
US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom
Code Information
Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018