FDA Device recall Z-1499-2018
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029
- FDA Device
- Class III
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class III recall of MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029 by Diagnostic Hybrids, citing A component of the kit was found to contain bacterial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1499-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-11-03 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostic Hybrids |
| Distribution | US |
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.
Reason
A component of the kit was found to contain bacterial contamination.
Identifiers
| code_info | Lot 052419 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1499-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.