Recall Z-2926-2018 ยท GKR System, Hemoglobin, Automated
Stanbio Laboratory, LP
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.
| Date | Feb 8, 2018 |
| Status | Terminated |
| Reason | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory, Jul 18, 2008 |