ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Reported: July 8, 2015 Initiated: July 22, 2014 #Z-1932-2015
Product Description
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Reason for Recall
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 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.
- Location
- Abbott Park, IL
Frequently Asked Questions
What product was recalled? ▼
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.. Recalled by Abbott Laboratories. Units affected: 11,215 units.
Why was this product recalled? ▼
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1932-2015.
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