ISE REF Valve — Class II medical device recall Z-0152-2014
Terminated recall by Beckman Coulter Inc., reported 2013-11-13, distributed nationwide. The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE un
| Recall number | Z-0152-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-09-09 |
| Classified | 2013-11-05 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, VN |
| Model numbers | 5427200, 5427300, 5427400, 5427600, 5427900, 5900100, 5900400, 5900600, 590220, 5902400, 5996100, 5996300, 5996500, 5998100, 6196400, 6196500, 6196700, A92928, A92929, AU2700, AU2700OPA, AU400, AU400OPA, AU5400, AU5400OPA and 77 more |
Product
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
Reason for recall
The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
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-0152-2014. 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.