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U.S. Department of Health and Human Services

Medical Devices

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Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell

Recall Class: Class I

Date Recall Initiated: January 4, 2010

Product: UniCel DxC Synchron Clinical System – Ion Selective Electrode (ISE) Flow Cell

All serial numbers with the following PN Numbers are affected by this recall.

PN Numbers
A10405 (UniCel DxC 600)
A11810 (UniCel DxC 600 PRO)
A27318 (UniCel DxC 600i)
A11816 (UniCel DxC 800)
A11812 (UniCel DxC 800 PRO)
A59102 (UniCel DxC 880i)
A64903 (UniCel DxC 680i)
A64871 (UniCel DxC 660i)
A64935 (UniCel DxC 860i)

This product has been manufactured and distributed since November 2004.

Use:

These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.

Recalling Firm:

Beckman Coulter Inc.
200 South Kramer Boulevard
Brea, California 92821-6208

Reason for Recall:

There may be excessive build-up of protein, bacteria, and sample tube additives in the instrument’s ion selective electrode flow cell which may cause incorrect sodium results.

Public Contact:

Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633.

FDA District: Los Angeles

FDA Comments:

On January 4, 2010, the company sent its customers a letter advising them of the incorrect sodium results derived from a build-up of protein, bacteria and additives in the ISE flow cell. The letter discussed the impact and actions to be taken along with some additional recommendations. Customers are to:

  • follow the new maintenance instructions included with the letter.
  • share the information with laboratory staff.
  • retain the notice as part of their Quality System documentation.
  • send a copy of the letter to any other laboratory who received the affected product.
  • complete and return the response form to the company.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.