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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc

DATE NOTIFICATION INITIATED:

April 21, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests
Product Code 723030

Lot SS188C (Expiration Date May 6, 2008)
Lot SS188D (Expiration Date July 24, 2008 )
Lot SS189A (Expiration Date October 30, 2008)
Lot SS189B (Expiration Date January 23, 2009)
Lot SS189C (Expiration Date April 8, 2009)

MANUFACTURER:

Ortho Clinical Diagnostics, Inc. (OCD)
Raritan, New Jersey

REASON:

Ortho-Clinical Diagnostics Inc. (OCD) has received complaints of weakened reactivity or false negative reactions for the positive controls when using these lots. Preliminary findings have shown that the source of saline and/or container used when performing the Indirect Antiglobulin Test using Anti-S can affect assay results. If you experience the weaken reactivity or false negative reactions with the positive control in your laboratory, you should consider using an alternate source of saline.

When the positive control does not perform as expected, the test is considered invalid and test results cannot be interpreted. OCD is not aware of any reported erroneous results related to this issue.

Effective immediately, OCD requires that you follow the Supplemental Test Procedure to continue using all in-date and future lots of Blood Grouping Reagent Anti-S.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448