Beckman Coulter AU5800 Clinical Chemistry Analyzer — Class II medical device recall Z-0913-2013
Terminated recall by Beckman Coulter Inc., reported 2013-03-13, distributed nationwide. Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reag
| Recall number | Z-0913-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-11-28 |
| Classified | 2013-03-06 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2014-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CH, CN, CZ, DE, ES, FR, GB, HU, IE, IL, IN, IT, KR, MY, NL, TR, TW, VN |
| Reason classes | software |
| Model numbers | A94907, A94908, A94909, A94910, A94912, A94913, A94914, A94915, A94917, A94918, A94919, A94920, A94922, A94923, A94924, A94925, AU5811-02, AU5811-03, AU5811-04, AU5811-06, AU5821-02, AU5821-03, AU5821-04, AU5821-06, AU5831-02 and 7 more |
Product
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0913-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.