Z-3127-2011

UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immunoassay Systems Part...

Name: Z-3127-2011 UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immunoassay Systems Part...
Creator: Beckman Coulter Inc.
Published: 2011-04-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-04-15 / Terminated

FDA source

Beckman Coulter Inc. began a recall of UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 UniCel DxI 600 Access Immunoassay Systems Part Numbers: A30260 UniCel DxC 600i, SYNCHRON Access... on 2011-04-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3127-2011
Status: Terminated
Initiated: 2011-04-15
Posted: 2012-01-30
Terminated: 2012-12-21
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
FDA root cause: Other
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.
Quantity in commerce: 3,382 units
Distribution: 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.
Product codes and lots: All Serial Numbers

Product code JJE

K023764Class IUnicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. / cleared 2003-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)