—#153847

Product

UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K922823
Affected lot / code info: Serial No. (Part No. A25637) 800999,801019 Serial No. (Part No. A25638)800995,800996,800997,800998,801000,801001,801002,801003,801004, 801005,801006,801007,801008,801009,801010,801011,801012,801013, 801014,801015,801016,801017,801018,801020,801021,801022,801023, 801024,801025,801026,801027

Why it was recalled

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

Root cause (FDA determination)

Software Design Change

Action the firm took

An Urgent Medical Device Recall letter was sent on 3/7/17 to inform customers that Beckman Coulter has determined through internal investigation that a circuit board that controls motor functions in the instrument systems listed above can affect device positioning on the pipettor and incubator belt while the instrument is running. Customers are informed of the impact, action to be taken, and the resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe

Timeline

Recall initiated: 2017-03-07
Posted by FDA: 2017-03-15
Terminated: 2018-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.