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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System-Haemonetics Corp

DATE NOTIFICATION INITIATED:

February 25, 2005

PRODUCT

Automated Blood Cell Separator, Haemonetics LN8150 Mobile Collection System, MCS+ 9000
Model Number: LN 08150-110-E
Serial Numbers: 05A047-05A048, 05A050, 05A064-05A072, 05A092-05A100, 05B017-05B023

MANUFACTURER:

Haemonetics Corp
Braintree, MA

REASON:

Haemonetics has discovered a manufacturing error on the MCS+ LN8150 CPU board that could affect display performance and result in inability to initiate a procedure or premature termination of a procedure. The problem would manifest itself in a display failure upon start-up or cause display failure intermittently during a procedure. The display would simply go blank.

A Haemonetics Field Service Engineer will contact consignees to replace the CPU boards in the devices referenced above. In the meantime, Haemonetics recommends not to use the devices until the circuit boards have been replaced.

 

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