FDA Device recall Z-0913-2013
Beckman Coulter AU5800 Clinical Chemistry Analyzer
- FDA Device
- Class II
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class II recall of Beckman Coulter AU5800 Clinical Chemistry Analyzer by Beckman Coulter, citing due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0913-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-28 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Reason
Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
Identifiers
| code_info | All serial numbers and all software versions 4.05 and prior. Part# Item# A94907 AU5811-02 A94912 AU5821-02 A94…All serial numbers and all software versions 4.05 and prior. Part# Item# A94907 AU5811-02 A94912 AU5821-02 A94917 AU5831-02 A94922 AU5841-02 A94908 AU5811-03 A94913 AU5821-03 A94918 AU5831-03 A94923 AU5841-03 A94909 AU5811-04 A94914 AU5821-04 A94919 AU5831-04 A94924 AU5841-04 A94910 AU5811-06 A94915 AU5821-06 A94920 AU5831-06 A94925 AU5841-06 |
|---|
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-0913-2013%22
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