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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of ORTHO Antibody to HBsAg ELISA Test System 3-Ortho Clinical Diagnostics

DATE RECALL INITIATED:

 

September 20, 2004

 

LOT NUMBER / EXPIRATION DATE :

 

HBK133 12/17/2004

MANUFACTURER:

Ortho Clinical Diagnostics
Raritan, New Jersey

REASON:

 

Ortho-Clinical Diagnostics, Inc. has confirmed complaints of positive control failures when using ORTHO Antibody to HBsAg ELISA Test System 3. This is due to low Optical Density (OD) values, less than 0.225, for the positive control, resulting in invalid plates. Customers have been asked to contact the manufacturer to arrange for product return.

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002