FDA-Device2018-09-05Class II
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.
Stanbio Laboratory, LP
Hazard
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
Sold states
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.
Affected count
2,804 devices
Manufactured in
1261 N Main St, N/A, Boerne, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2926-2018Don't want to check this manually?
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