Device recall

Z-2552-2025: Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant…

FDA device recall · Class II · Quest International, Inc.

Key facts

Recall number (Z-number) Z-2552-2025
Recall event 97419
Product 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…
Product code PCL
Recalling firm Quest International, Inc.
Recall class Class II
Status Open, Classified
FEI number 3000206132

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)