Recall Z-2926-2018
Stanbio Laboratory, LP · initiated February 8, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial number range of affected power adapters: 41800001-41804000
Reason for recall
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recall was initiated via letter dated 2/7/2018 by first class mail letter on 2/8/2018 instructing the consignee to stop using the adapter if it is affected and it will be replaced.
Details
- Recall number
- Z-2926-2018
- Initiated
- February 8, 2018
- Terminated
- September 4, 2020
- Product code
- GKR – System, Hemoglobin, Automated
- Quantity
- 2,804 devices
- Distribution
- 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.
- Recalling firm
- Stanbio Laboratory, LP, Boerne, TX