Recall Z-1932-2015 ยท CEM Electrode, Ion Specific, Potassium
Abbott Laboratories
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
| Date | Jun 27, 2015 (initiated Jul 22, 2014) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |