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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Notification: Blood Grouping Reagent Anti-Lea BioClone 2.0-Ortho Clinical Diagnotics, Inc.

DATE NOTIFICATION INITIATED:

October 30, 2007


PRODUCT / LOT NUMBER / EXPIRATION DATE:


Blood Grouping Reagent Anti Lea BioClone 2.0
 

 

Product Code 715280
Lot Number
Product Code 6901859
Lot Number
Expiration Date
LAB129A LAB129AX 3/10/2008
LAB130A LAB130AX 6/29/2008
LAB131A LAB131AX 12/27/2008

 


MANUFACTURER:

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

REASON:

OCD has received complaints of weakened reactivity or false negative reactions when using the referenced lots. Their investigation has confirmed decreased potency, weakened reactivity and, in some cases, false negative results. OCD is requiring customers to discontinue using and discard any remaining inventory.

 

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