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.
This recall has been terminated (originally issued November 3, 2015).
- Company
- Diagnostic Hybrids, Inc.
- Recall Initiated
- November 3, 2015
- Terminated
- August 28, 2020
- Recall Number
- Z-1499-2018
- Quantity
- 72 kits
- Firm Location
- Athens, OH
- Official Source
- View on FDA website ↗
Reason for Recall
A component of the kit was found to contain bacterial contamination.
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.
Lot / Code Info
Lot 052419
Root Cause
Material/Component Contamination
Action Taken
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.
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