Important Notification
Blood Grouping Reagent Anti-Lea BioClone 2.0
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.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.