FDA Device recall Z-0534-2026
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version…
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version… by Quest International, citing due to distributing the measles IgG IVD without a premarket approved/cleared.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0534-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-01 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Quest International |
| Distribution | UT, WA |
Product
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Reason
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Identifiers
| code_info | Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0534-2026%22
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