Beckman Coulter AU5800 Clinical Chemistry Analyzer — Class II medical device recall Z-1873-2013
Terminated recall by Beckman Coulter Inc., reported 2013-08-14, distributed nationwide. Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the dilute
| Recall number | Z-1873-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-10-26 |
| Classified | 2013-08-02 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2013-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CH, CN, DE, ES, FR, GB, HU, IE, IL, IN, IT, JP, KR, MY, NL, TR, TW, VN |
| Reason classes | labeling |
| Model numbers | A94906, AU5811-01 |
Product
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
Reason for recall
Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
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-1873-2013. 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.