Device 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.
Z-2730-2017
Product summary
- Event
- Event 77364
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4444 AQUA CAL Level 1 kits
- Official record key
device-enforcement:Z-2730-2017
Official wording
Reason: The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
Code information: Lot No. 72645074, Exp. Date 30 Apr 2018
Distribution pattern: US Nationwide Distribution in the states of AL, AR, AK, CA, CO, DE, FL, GA, ID, IL, IN, IO, KS, KY, LA, MA, MD, MS, MI, ME, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WV, WI, and Puerto Rico Brunei, Canada, China, Czech Republic, France, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, Panama, Paraguay, Philippines, Qatar, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates, & United Kingdom.
Derived failure modes
-
Unknown
The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.