Alinity ci-Series System Control Module (2019-05-23)
- 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
Affected Products
Alinity ci-Series System Control Module
Reason
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).
Affected products
Alinity ci-Series System Control Module
Lot or serial number
All lots.
Model or catalog number
03R70-01
Companies
- Manufacturer
-
Abbott GmbH & Co. KG
Max-Planck-Ring 2
Wiesbaden
65205
GERMANY