Recall Z-1932-2015
Abbott Laboratories · initiated July 22, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Codes / lots: Lot numbers: 21399UN13 (Expiration date: 5AUG2014), 67873UN13 (Expiration date: 12NOV2014), 74710UN13 (Expiration date: 8DEC2014), 82008UN13 (Expiration date: 14JAN2015), 88884UN13 (Expiration date: 4FEB2015)
Reason for recall
ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
FDA-determined cause: Process control
Action taken
Customers who received shipments of the affected lots were sent a Product Correction letter on July 22, 2014.
Details
- Recall number
- Z-1932-2015
- Initiated
- July 22, 2014
- Posted by FDA
- June 27, 2015
- Terminated
- July 21, 2015
- Product code
- CEM – Electrode, Ion Specific, Potassium
- 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…
- Recalling firm
- Abbott Laboratories, Abbott Park, IL