Recall Z-2552-2025 ยท PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Quest International, Inc.
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component
| Date | Sep 11, 2025 (initiated Jul 17, 2025) |
| Status | Open, Classified |
| Reason | Measles IgM Test Kit lacks premarket approval or clearance. |
| Root cause | No Marketing Application |
| Action | On July 17, 2025, Quest International, Inc. issued a "Urgent: Medical Device Recall Notification to affected consignees via E-Mail. Quest International asked consignees to take the following actions: 1. Please examine your inventory and quarantine the affected lot. In addition, if you have distributed the product, you must identify all customers that have received the affected product and immediately notify them. 2. Please ask your customers to discontinue the use of the affected product(s) lot of the Measles IgM Test Kit immediately. 3. We ask that you and your customers discard all aff |
| Quantity | 376 kits |
| Distribution | US Nationwide distribution in the states of Utah, Texas, and Arizona. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.