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.
Reported: July 19, 2017 Initiated: May 15, 2017 #Z-2730-2017
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.
Details
- Recalling Firm
- Beckman Coulter Inc
- Units Affected
- 4444 AQUA CAL Level 1 kits
- Distribution
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc. Units affected: 4444 AQUA CAL Level 1 kits.
Why was this product recalled? ▼
The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2730-2017.
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