Device recall

Z-1629-2022: BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR…

FDA device recall · Class II · Mckesson Medical-Surgical Inc. Corporate Office

Key facts

Recall number (Z-number) Z-1629-2022
Recall event 90336
Product BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ…
Product code GGK
Recalling firm Mckesson Medical-Surgical Inc. Corporate Office
Recall class Class II
Status Open, Classified
FEI number 3004386693

At a glance

  • None Linked 510(k)s
  • 10–99 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)