ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
- Company
- Abbott Laboratories
- Recall Initiated
- July 22, 2014
- Posted
- June 27, 2015
- Terminated
- July 21, 2015
- Recall Number
- Z-1932-2015
- Quantity
- 11,215 units
- Firm Location
- Abbott Park, IL
Reason for Recall
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
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.
Lot / Code Info
Lot numbers: 21399UN13 (Expiration date: 5AUG2014), 67873UN13 (Expiration date: 12NOV2014), 74710UN13 (Expiration date: 8DEC2014), 82008UN13 (Expiration date: 14JAN2015), 88884UN13 (Expiration date: 4FEB2015)
Root Cause
Process control
Action Taken
Customers who received shipments of the affected lots were sent a Product Correction letter on July 22, 2014.