Device recall

Z-0309-2024: AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution…

FDA device recall · Class II · Beckman Coulter Biomedical Division

Key facts

Recall number (Z-number) Z-0309-2024
Recall event 93206
Product AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in…
Product code DDD
Recalling firm Beckman Coulter Biomedical Division
Recall class Class II
Status Open, Classified
510(k) numbers K963139
FEI number 1000206808

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)