ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
FDA device recall Z-1932-2015 · posted 2015-06-27 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
- Action taken
- Customers who received shipments of the affected lots were sent a Product Correction letter on July 22, 2014.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CEM
- Quantity 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,
- Date initiated
- 2014-07-22
- Date posted
- 2015-06-27
- Date terminated
- 2015-07-21
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |