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U.S. Department of Health and Human Services

Class 2 Device Recall ICT Serum Calibrator

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  Class 2 Device Recall ICT Serum Calibrator see related information
Date Initiated by Firm July 22, 2014
Date Posted June 27, 2015
Recall Status1 Terminated 3 on July 21, 2015
Recall Number Z-1932-2015
Recall Event ID 71302
510(K)Number K980367  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product ICT Serum Calibrator REF 146-03.

For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Code Information Lot numbers: 21399UN13 (Expiration date: 5AUG2014), 67873UN13 (Expiration date: 12NOV2014), 74710UN13 (Expiration date: 8DEC2014), 82008UN13 (Expiration date: 14JAN2015), 88884UN13 (Expiration date: 4FEB2015)
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact
847-937-2550
Manufacturer Reason
for Recall		 ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
FDA Determined
Cause 2		 Process control
Action Customers who received shipments of the affected lots were sent a Product Correction letter on July 22, 2014.
Quantity in Commerce 11,215 units
Distribution Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Afghanistan, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Curacao, North Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mauritania, Mauritius, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Calicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
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 = CEM and Original Applicant = ABBOTT LABORATORIES
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