Alinity ci-Series System Control Module (2019-05-23)
Press Release
By:
Ref: Health Canada
Published: 06/07/2019
Starting date:
May 23, 2019
Posting date:
June 7, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70129
Last updated:
2019-06-07
Alinity ci-Series System Control Module
Abbott has identified an issue with all on market versions of Alinity ci-series software where the software may not detect an issue on the Alinity c integrated chip technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-). Abbott will be releasing Alinity ci-series software version 2.6.1 to change the ICT reference solution voltage drift threshold from 10mV to 3mV to improve the ability of the system to detect ICT reference solution voltage drift. ICT issues may cause incorrect patient results for the Na+, K+, and Cl- assays for all specimen types (serum, plasma, and urine).
All lots.
03R70-01
Manufacturer
Abbott GmbH & Co. KG Max-Planck-Ring 2 Wiesbaden 65205 GERMANY