Urgent Notification: Package Insert Update for MLB2 Modified LISS Solution - Biotest AG

Package Insert Update for MLB2 Modified LISS Solution

DATE NOTIFICATION INITIATED:

February 12, 2009

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Package Insert Number 187734 Version 06
Product Number: 805 200 100

Lot Number	Expiration Date
7738020	10/04/2009
7830101	07/31/2010

MANUFACTURER:

Biotest AG - Dreiech
Dreieich, Germany

REASON:

Biotest has notified their customers regarding an ambiguous statement in their package insert which incorrectly stated the centrifugation parameter. The centrifugation parameter should be 20 seconds at (800-1000 x g) for tube testing. Customers are requested to replace the product insert version 06 with the new package insert version 07.

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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.