FDA Device recall Z-2258-2012
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260 by Beckman Coulter, citing the recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause err….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2258-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-13 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The 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.
Reason
The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
Identifiers
| code_info | Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. |
|---|
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-2258-2012%22
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