Device product
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Z-1499-2018
Product summary
- Event
- Event 79642
- Status
- Terminated
- Classification
- Class III
- Quantity
- 72 kits
- Official record key
device-enforcement:Z-1499-2018
Official wording
Reason: A component of the kit was found to contain bacterial contamination.
Code information: Lot 052419
Distribution pattern: Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
Derived failure modes
-
Microbial contamination
bacterial contamination