The Recall Desk
SevereFDA (Devices)·Z-2926-2018·Announced 2018-09-05

Stanbio AC Power Adapter Recall for HemoPoint H2 Meter

Stanbio Laboratory is recalling AC power adapters for the HemoPoint H2 meter because the adapter plate may crack or detach, exposing live electrical contacts.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that exposes live electrical contacts, posing a risk of electric shock, which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Stanbio Laboratory, LP is recalling 2,804 AC power adapters for the HemoPoint H2 meter, Model G3000 series. The adapters were distributed nationwide and to several foreign countries, including Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname. The affected adapters have serial numbers ranging from 41800001 to 41804000.

The recall was initiated because the US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet. This failure can expose live electrical contacts, posing a risk of electric shock. The agency classified this recall as Class II.

Consumers should stop using the affected power adapters immediately. Stanbio Laboratory will provide a replacement adapter at no cost. Users can contact the company for more information or to arrange the replacement.

The recalled product

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.
Affected units
2,804

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial number range of affected power adapters: 41800001-41804000

Distribution

Distributed nationwide across the United States.