Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Microbiology · 21 CFR 866.3520
The qualitative detection of measles specific IgM antibodies in serum or plasma.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Quest International, Inc.Open, ClassifiedSep 11, 2025
Brand Name: ReQuest Measles IgM
Measles IgM Test Kit lacks premarket approval or clearance.
Z-2552-2025 · View FDA record ↗ - Clark Laboratories, Inc. (dba,Trinity Biotech USA)TerminatedSep 12, 2016
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
Z-2782-2016 · View FDA record ↗ - Clark Laboratories, Inc.TerminatedUnknown
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Z-1503-2021 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code