Device recall

Z-0912-05: i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated…

FDA device recall · Class II · Abbott Laboratories

Key facts

Recall number (Z-number) Z-0912-05
Recall event 31502
Product i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
Product code JBP
Recalling firm Abbott Laboratories
Recall class Class II
Status Terminated
Termination date Jun 30, 2006
510(k) numbers K992571
FEI number 2245578

At a glance

  • 1–9 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)