All Recalls

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Lack of assurance of sterility

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

Lack of assurance of sterility

Lack of assurance of sterility

Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

Potential for difficulty in safety mechanism activation.