Stanbio Laboratory

Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

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

All patient serum samples yield a weakly positive test result.