Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.
Products Sold
Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.
Beckman Coulter Inc is recalling UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier due to The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
Recommended Action
Per FDA guidance
A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026