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Terminated

UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immunoassay Systems Part Numbers: A30260 UniCel DxC 600i, SYNCHRON Access Clinical Systems Part Numbers: A25656 UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems Part Numbers: A64871, A64903, A64935, A59102 Subsequent Product Codes: CEM The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

FDA Recall Z-3127-2011 · Posted 2012-01-30

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2011-04-15
Date Terminated2012-12-21
Product Quantity3,382 units

Reason for Recall

The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i

Firm Action

Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter includes information on the new room temperature operating range for all UniCel DxI Immunoassay Systems and Access Immunoassay Systems during system operation. Customers were instructed to review their historical room temperature records to determine if their Access Immunoassay System and UniCel DxI Immunoassay System were operating outside the revised temperature range. An attached Response Form was included for customers to complete and return. Please contact Beckman Coulter Customer Support Center for questions regarding this notice at 1-800-854-3633.

Root Cause

Other

Distribution Pattern

Worldwide Distribution--USA (nationwide) and Puerto Rico and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayette, Mexico, Morocco, Nambia, Netherlands, New Zealand, Norway, Philippines, Poland,, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023764UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100Beckman Coulter, Inc. · 2003-01-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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