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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron AQUA CAL Level 1, 2 & 3

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  Class 2 Device Recall Synchron AQUA CAL Level 1, 2 & 3 see related information
Date Initiated by Firm May 15, 2017
Date Posted July 13, 2017
Recall Status1 Terminated 3 on September 09, 2020
Recall Number Z-2730-2017
Recall Event ID 77364
510(K)Number K071277  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
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.
Code Information Lot No. 72645074, Exp. Date 30 Apr 2018
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Customer Service
800-526-3821
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Recall notices will be sent via mail or email to customers the week of 05/15/2017. Customers are instructed to discard the affected calibrator and request a replacement. Call Client Services at (800) 526-3821 (US only)
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = BECKMAN COULTER, INC.
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