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Recall Observatory FDA recall evidence

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

May 15, 2017

Class II

Product summary

Firm
Beckman Coulter Inc
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

    reason.no_named_rule · v1.0.0

    The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.