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Vaccines, Blood & Biologics

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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.

    
 

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  • Consumer Affairs Branch (CBER)

  • (800) 835-4709
  • (301) 827-1800
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    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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