Hepatitis B Diagnostic Kit Recalled by Manufacturer

Ortho-Clinical Diagnostics recalls kits due to false negative results

WEDNESDAY, Jan. 11 (HealthDay News) -- The U.S. Food and Drug Administration has issued a Class I recall of the VITROS Immunodiagnostic HBsAg Confirmatory Kit because it can result in false negatives for hepatitis B-infected patients, which is particularly hazardous for pregnant women. Class I is a recall in which there is "a reasonable probability that use of the product will cause serious injury or death," according to the FDA.

Samples that initially prove positive may give a "not confirmed" result due to an unknown component in the diluting solution, which could lead to a false negative result.

"False negative results may prevent some patients... from receiving necessary treatment," according to the recall notice issued by the FDA Center for Devices and Radiological Health. "This is especially true for pregnant women whose tests show false negative results." Infants of hepatitis B-positive mothers who are not treated have a 90% chance of developing chronic hepatitis B infection.

On Dec. 15, the manufacturer, Ortho-Clinical Diagnostics of Rochester, N.Y., sent letters to medical facilities and laboratories with instructions to discontinue use of the test kit and not to use up any remaining inventory. It also recommended a review of previous results derived from using the test.

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