Z-2730-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- May 15, 2017
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4444 AQUA CAL Level 1 kits
Product Description
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.
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.
Code Information
Lot No. 72645074, Exp. Date 30 Apr 2018