UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access… — Class II medical device recall Z-2272-2016
Terminated recall by Beckman Coulter Inc., reported 2016-08-03, distributed in PR. Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
| Recall number | Z-2272-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2014-04-22 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-02-09 |
| Distributed | PR |
| Countries outside the US | AE, AU, BE, BG, CA, CH, CN, CO, CR, CZ, DE, DK, EG, ES, FI, FR, GB, GR, GT, HK, ID, IE, IN, IT, JO, JP, KR, KW, LB, LT, MA, MX, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, TH, TN, TR, TW, VN, ZA |
| Reason classes | packaging |
| Model numbers | 70300, 970300 |
Product
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clinical Systems UniCel DxC 660i Synchron Access Integrated Clinical Systems Product Labeling Reference No. A93719 For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Reason for recall
Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
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-2272-2016. 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.