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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of m2000sp Instrument-Abbott Molecular, Inc.

DATE RECALL INITIATED:

August 25, 2008

PRODUCT / LOT NUMBER:

Hood Assembly for the Abbott m2000sp (List 9K14-01 and 9K14-02) Automated Sample Preparation System

MANUFACTURER:

Abbott Molecular, Inc.
Des Plaines, Illinois

REASON:

Abbott recently identified that the hood front window may detach from the window stud plates that attach the window to the m2000sp instrument. Customers are asked to take care to monitor the adhesion of the hood front window to the window stud plates. An Abbott Molecular Field Service Representative will replace the adhesive at the next service call.

 

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