Device product
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
Z-1321-2013
Product summary
- Event
- Event 64650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 kits in total
- Official record key
device-enforcement:Z-1321-2013
Official wording
Reason: CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Code information: Catalog Number 4503223, Lot #142345647, Exp: 06/09/14
Distribution pattern: USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
Derived failure modes
-
Unknown
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.