Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2926-2018

February 08, 2018

Class II

Product summary

Firm
Stanbio Laboratory, LP
Event
Event 80562
Status
Terminated
Classification
Class II
Quantity
2,804 devices
Official record key
device-enforcement:Z-2926-2018

Official wording

Reason: The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

Code information: Serial number range of affected power adapters: 41800001-41804000

Distribution pattern: Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.