Hepatitis B test kit recalled.
An unknown component in the diluting solution that is used to test blood and serum samples may produce "not confirmed" results for samples that are found to be positive with the initial test, resulting in false negatives.
False-negative results may prevent some patients who are infected with or carrying the virus from receiving necessary treatment. The possibility of false-negative results is of particular concern for pregnant women. "When their fetuses are born, they will be presumed negative, and [will not be] treated with the 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," according to the FDA.
In mid-December, the company sent letters to medical facilities, testing laboratories, and public health agencies instructing customers to discontinue use of the kits and discard any remaining inventory. Previously reported results should be reviewed. Those with questions should contact Ortho-Clinical Diagnostics' Judy M. Strzepek by calling 908-218-8524.
A class I recall is the most serious type of FDA recall. It involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.
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|Title Annotation:||Ortho-Clinical Diagnostics Inc recalls|
|Author:||Splete, Heidi; Wachter, Kerri|
|Publication:||Internal Medicine News|
|Article Type:||Brief article|
|Date:||Mar 15, 2006|
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