FDA Device recall Z-0345-2013
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457 by Beckman Coulter, citing the recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe as….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0345-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-08-01 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel 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. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Reason
The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Identifiers
| code_info | Serial Numbers: 600000 through 602389 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0345-2013%22
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