Device product
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.
Z-1320-2013
Product summary
- Event
- Event 64650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 kits in total
- Official record key
device-enforcement:Z-1320-2013
Official wording
Reason: CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Code information: Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 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.