Synchron LXi 725 Clinical System — Class II medical device recall Z-1034-2013
Terminated recall by Beckman Coulter Inc., reported 2013-04-10, distributed nationwide. Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that m
| Recall number | Z-1034-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-02-12 |
| Classified | 2013-04-01 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2013-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BG, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LV, NL, PL, PT, RO, SE, SI, SK, TR |
| Quantity | 83 units |
| Model numbers | A15642 |
Product
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Reason for recall
Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
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-1034-2013. 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.