AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800… — Class II medical device recall Z-1167-2013
Terminated recall by Beckman Coulter Inc., reported 2013-05-01, distributed in CA, GA, IL, IN, KS, MA, MI, NC…. Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause
| Recall number | Z-1167-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-03-20 |
| Classified | 2013-04-24 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2014-09-16 |
| Distributed | CA, GA, IL, IN, KS, MA, MI, NC, NJ, NV, NY, OH, PA, PR, TX, UT, VA, WI |
| Countries outside the US | AU, BE, BR, CA, CH, CN, CZ, DE, ES, FR, GB, HK, IE, IL, IN, IT, JP, MY, NL, TR, TW, VN |
| Quantity | 490 |
| Reason classes | software |
| Model numbers | A91921, A91949, A94906, A94907, A94908, A94909, A94910, A94911, A94912, A94913, A94914, A94915, A94916, A94917, A94918, A94920, A94922, A94923, A94924, A94925, AU5811-01, AU5811-02, AU5811-03, AU5811-04, AU5811-06 and 15 more |
Product
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.
Reason for recall
Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
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-1167-2013. 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.