Ortho-Clinical Diagnostics VITROS Immunodiagnostic HBsAg Confirmatory Kit

The Food and Drug Administration (FDA) released the following information:

Ortho-Clinical Diagnostics and FDA notified healthcare professionals and clincal laboratory staff of a class 1 recall of the HBsAg Confirmatory Kit due to an unknown component in the diluting solution used to test blood and serum samples that may produce 'Not Confirmed' results for samples found to be positive with the initial test. This can cause some results to be classified as false negatives. False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results. The company recommends that previously reported results be reviewed.

The HBsAg Confirmatory Kit is used to confirm the presence of Hepatitis B surface antigen in human blood and plasma that has initially been found to be reactive using the VITROS Immunodiagnostic Products HBsAg Reagent Pack . 
 
False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results. When their fetuses are born, they will be presumed negative, and not treated with the HBIG (hepatitis B immunoglobulin) and hepatitis B vaccine. Such infants have a 90% chance of progressing to chronic hepatitis B virus infection resulting in possible liver transplantation or early death.

Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.