Health product recall

Alinity ci-Series System Control Module (2020-06-26)

Starting date:
June 26, 2020
Posting date:
July 10, 2020
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-73513

Last updated:
2020-07-10

Affected Products

Alinity ci-Series System Control Module

Reason

Abbott has identified two issues with quality control (QC) functionality, after an assay file update, that impacts all Alinity ci-series software versions.

Affected products

Alinity ci-Series System Control Module

Lot or serial number

All serial numbers.

Model or catalog number

03R70-01

Companies
Manufacturer

Abbott GmbH

Max Planck Ring 2

Wiesbaden

65205

GERMANY