Device recall

Z-2926-2018: Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The…

FDA device recall · Class II · Stanbio Laboratory, LP

Key facts

Recall number (Z-number) Z-2926-2018
Recall event 80562
Product Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
Product code GKR
Recalling firm Stanbio Laboratory, LP
Recall class Class II
Status Terminated
Termination date Sep 4, 2020
510(k) numbers K081719
FEI number 1616487

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)