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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of m2000sp and m1000 Instrument-TECAN Schweiz AG / Abbott Molecular, Inc.

DATE RECALL INITIATED:

June 12, 2007

PRODUCT / LOT NUMBER:

m2000sp Instrument and m1000 Instrument
List Numbers 9K14-01 and 4J72-01
Not Serial Number Specific)

MANUFACTURER:

TECAN Schweiz AG
Switzerland

DISTRIBUTOR:

Abbott Molecular, Inc.
Des Plaines, IL

REASON:

Abbott has recently identified that spring clips on the Disposable Tips (DiTi) Racks, shipped with or ordered independent of m2000sp or m1000 Instruments, may have sharp protruding corners. Customers are asked to take care to avoid injury from sharp corners on the spring clips when handling the DiTi racks on the m2000sp or m1000 Instrument.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002