Device recall

Z-0274-2022: Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite…

FDA device recall · Class II · The Binding Site Group, Ltd.

Key facts

Recall number (Z-number) Z-0274-2022
Recall event 88921
Product Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Product code DEH
Recalling firm The Binding Site Group, Ltd.
Recall class Class II
Status Terminated
Termination date Feb 4, 2025
510(k) numbers K140396
FEI number 3002808340

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)