Recall Z-0534-2026 ยท LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Quest International, Inc.
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
| Date | Nov 17, 2025 (initiated Oct 1, 2025) |
| Status | Open, Classified |
| Reason | Due to distributing the measles IgG IVD without a premarket approved/cleared. |
| Root cause | No Marketing Application |
| Action | On 10/01/2025, the firm email an "URGENT: Medical Device Recall Measles IgG IFU" letter to customers informing them that the Measles IgG Medical Device is subject to the limitations of exemption from premarket notification (510(k)) under 21 CFR866.9(c)(7) and is subject to the 510(k) premarket requirements prior to being marketed and distributed in the U.S. Customers are instructed to examine their inventory, discontinue use and quarantine the affected lot and review the updated Instruction for Use (IFU) and ensure all relevant personnel are informed of the changes. The previous version of t |
| Distribution | All products were distributed in the United States. (Utah, Washington). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.