Device recall

Z-0171-2016: BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody…

FDA device recall · Class III · Becton, Dickinson and Company, BD Biosciences

Key facts

Recall number (Z-number) Z-0171-2016
Recall event 72321
Product BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Product code LIZ
Recalling firm Becton, Dickinson and Company, BD Biosciences
Recall class Class III
Status Terminated
Termination date Oct 18, 2016
510(k) numbers K842218
FEI number 2916837

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

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