Device product
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Z-2596-2018
Product summary
- Firm
- QIAGEN
- Event
- Event 80430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 287 pcs
- Official record key
device-enforcement:Z-2596-2018
Official wording
Reason: Underfilled reagent well that could lead to incorrect results
Code information: UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19
Distribution pattern: Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
Derived failure modes
-
Unknown
Underfilled reagent well that could lead to incorrect results