Beckman Coulter Synchron AQUA CAL Level 1 — Class II medical device recall Z-2730-2017
Terminated recall by Beckman Coulter Inc, reported 2017-07-19, distributed nationwide. The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrate
| Recall number | Z-2730-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc, Brea, CA, United States |
| Recall initiated | 2017-05-15 |
| Classified | 2017-07-13 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CZ, FR, GB, GT, HK, IE, IN, IT, JP, LB, MX, NL, PA, PH, PY, QA, TH, TR, TW, ZA |
| Lot numbers | 72645074 |
| Model numbers | 471288 |
| Expiration dates | 2018-04-30 |
Product
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
Reason for recall
The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
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-2730-2017. 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.