Drug recall
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of…
FDA recall event 77364 · Class II · Beckman Coulter Inc
Key facts
| Event ID | 77364 |
|---|---|
| Recall numbers | Z-2730-2017 |
| Recalling firm | Beckman Coulter Inc |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | May 15, 2017 |
| Report date | Jul 19, 2017 |
| Termination date | Sep 9, 2020 |
| City | Brea |
| State | CA |
| Country | United States |
| FEI number | 2050011 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: