FDA Medical Device Recalls (openFDA)
Abbott Laboratories: ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
- Recall number
- Z-1932-2015
- Recalling firm
- Abbott Laboratories
- Product
- ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
- Status
- Terminated
- Initiated
- 2014-07-22
- Posted
- 2015-06-27
- Terminated
- 2015-07-21
- Reason
- ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
- Root cause
- Process control
- Action
- Customers who received shipments of the affected lots were sent a Product Correction letter on July 22, 2014.
- Quantity
- 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.
- Lot, serial or model codes
- Lot numbers: 21399UN13 (Expiration date: 5AUG2014), 67873UN13 (Expiration date: 12NOV2014), 74710UN13 (Expiration date: 8DEC2014), 82008UN13 (Expiration date: 14JAN2015), 88884UN13 (Expiration date: 4FEB2015)
- 510(k) numbers
- ["K980367"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28