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.