Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-2730-2017

U.S. FDA — Device Enforcement · United States · 2017-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2730-2017
Date of alert
2017-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
72645074
Reported risk: The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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