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Vaccines, Blood & Biologics

Recall of m2000sp Instrument-Abbott Molecular

DATE RECALL INITIATED:

June 30, 2008

PRODUCT / LOT NUMBER:

Solid Waste Chute (DiTi Slide) for use with the Abbott m2000sp (List 9K14-01 and 9K14-02) Automated Sample Preparation System

CONTRACT MANUFACTURER:

TECAN Schweiz AG
Switzerland

DISTRIBUTOR:

Abbott Molecular
Des Plaines, IL

REASON:

Abbott has recently identified that the solid waste chute (DiTi Slide 04J72-29) may have sharp edges. Customers are asked to take care to avoid injury from sharp edges on the solid waste chute when performing cleaning of this part on your m2000sp 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

Page Last Updated: 06/27/2013
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