Device recall

Z-1940-2010: BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer…

FDA device recall · Class II · BD Biosciences, Systems & Reagents

Key facts

Recall number (Z-number) Z-1940-2010
Recall event 55654
Product BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
Product code GKZ
Recalling firm BD Biosciences, Systems & Reagents
Recall class Class II
Status Terminated
Termination date May 18, 2011
510(k) numbers K050191
FEI number 2916837

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)