Device recall

Z-1148-03: Access Immunoassay System Technical Update 03.1, Part number 387851, Software…

FDA device recall · Class III · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-1148-03
Recall event 26726
Product Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
Product code KLS
Recalling firm Beckman Coulter Inc
Recall class Class III
Status Terminated
Termination date Apr 20, 2004
510(k) numbers K922823
FEI number 2050012

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)