Recalls for Enzyme Linked Immunoabsorbent Assay, Rubeola Igm

Measles IgM Test Kit lacks premarket approval or clearance.

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).

Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting