FDA Recall
Terminated
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.
Recall: Z-1499-2018
·
Initiated November 3, 2015
Recall
- Recall Number
- Z-1499-2018
- Event Number
- 79642
- Firm
- Diagnostic Hybrids, Inc.
- FEI Number
- 1000122536
- Product Code
- N/A
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- November 3, 2015
- Terminated
- August 28, 2020
- Address
- 2005 E State St, Ste 100, Athens, OH, 45701-2125
Description
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.
Reason
A component of the kit was found to contain bacterial contamination.
Action
Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.
Distribution
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.
Quantity
72 kits