• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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 NumberExpiration Date
773802010/04/2009
783010107/31/2010

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.


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.

 

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