Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit
Class 1 Recall
|December 15, 2005|
VITROS ® Immunodiagnostic HBsAg Confirmatory Kit
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 .
|Reason for Recall:|
An unknown component in the diluting solution used to test blood and serum samples may produce 'Not Confirmed' results for samples found to be positive with the initial test, which can cause some results to be classified as false negatives.
Judy M. Strzepek
New York Upstate
|Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.|