Potential for False Positive, Negative Results Using VITROS HIV Combo Reagent Pack

Potential for False Positive and False Negative Results Reported Using VITROS Immunodiagnostic Products HIV Combo Reagent Pack

Hospitals and labs nationwide have been notified that Ortho Clinical Diagnostics, a third party testing vendor, has reported issues affecting VITROS Immunodiagnostic Products HIV Combo Reagent Pack. The vendor has determined that certain lots have the potential to report false repeat reactive and false negative results. As a result, the testing vendor has instructed that the affected lots be discontinued and discarded.

UCHealth has discontinued the use of all affected lots. In addition, UCHealth has notified impacted patients and physicians.

What UCHealth is doing in response to this issue:

• Any positive result is automatically sent for secondary confirmation. Therefore, if a patient received a positive result from UCHealth, the result has been confirmed.
• Patients who received a negative result have been notified and offered retesting at no cost.  

If you have questions about your medical care, please contact your primary care provider.

We sincerely apologize for any trouble this recall may cause. UCHealth is committed to our patients’ safety and excellent medical care.