Health product recall

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