Recall Z-1498-2018 ยท OTR Research Use Only/Immunology Devices
Diagnostic Hybrids, Inc.
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
| Date | Nov 3, 2015 |
| Status | Terminated |
| Reason | A component of the kit was found to contain bacterial contamination. |
| Root cause | Material/Component 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. |
| Quantity | 107 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.