Device recall

Z-0397-2011: BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD…

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

Key facts

Recall number (Z-number) Z-0397-2011
Recall event 56048
Product BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).
Product code MVU
Recalling firm BD Biosciences, Systems & Reagents
Recall class Class II
Status Terminated
Termination date Dec 3, 2010
FEI number 2916837

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)