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Terminated

UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier

FDA Recall Z-0583-06 · Posted 2006-03-03

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2006-02-06
Date Terminated2012-03-06
Product Quantity280 total (263 in US & 17 in Canada)

Reason for Recall

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)

Firm Action

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)

Root Cause

Software design

Distribution Pattern

Nationwide and Canada

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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