Class 1 Recall: Ortho-Clinical Diagnostics VITROS® Immunodiagnostic HBsAg Confirmatory Kit

Date Recall
Initiated:

December 15, 2005

Product:

VITROS ® Immunodiagnostic HBsAg Confirmatory Kit

Use:

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 .

Recalling Firm:

Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester , New York 14626-5101

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.

Public Contact:

Judy M. Strzepek
Director, WW Quality Systems and Compliance
Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
Raritan , NJ 08869
908-218-8524

FDA District:

New York Upstate

FDA Comments:

• 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.
• Ortho-Clinical sent letters via overnight mail to medical facilities, testing labs and public health agencies on 12/15/2005, instructing customers to discontinue use and discard remaining inventory. In a separate Q&A sheet, the company recommends that previously reported results be reviewed.

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.