Device recall

Z-2880-2026: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog…

FDA device recall · Class III · Siemens Healthcare Diagnostics, Inc.

Key facts

Recall number (Z-number) Z-2880-2026
Recall event 99379
Product Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Product code KLR
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class III
Status Open, Classified
510(k) numbers K801204
FEI number 2517506

At a glance

  • 1–9 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)