Z-1932-2015Class II

ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride...

Name: Z-1932-2015 ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride...
Creator: Abbott Laboratories
Published: 2014-07-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-07-22 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays on 2014-07-22. FDA classified it as Class II and gives the reason as "ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1932-2015
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2015-06-27
Terminated: 2015-07-21
Recalling firm: Abbott Medical
Product: ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot numbers: 21399UN13 (Expiration date: 5AUG2014), 67873UN13 (Expiration date: 12NOV2014), 74710UN13 (Expiration date: 8DEC2014), 82008UN13 (Expiration date: 14JAN2015), 88884UN13 (Expiration date: 4FEB2015)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1932-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1932-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-27

Product code CEM

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)