UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
This recall has been terminated (originally issued March 3, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- February 6, 2006
- Posted
- March 3, 2006
- Terminated
- March 6, 2012
- Recall Number
- Z-0583-06
- Quantity
- 280 total (263 in US & 17 in Canada)
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
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)
Distribution
Nationwide and Canada
Lot / Code Info
Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.
Root Cause
Software design
Action Taken
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)