Device recall

Z-2976-2026: Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23…

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

Key facts

Recall number (Z-number) Z-2976-2026
Recall event 99446
Product Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Product code LBZ
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K011605
FEI number 1219913

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)