Health product recall

Instrument Manager (IM) Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0004 & v8.00.0005 (2021-04-29)

Starting date:
April 29, 2021
Posting date:
June 10, 2021
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-75775

Last updated: 2021-06-10

Affected Products 

Instrument Manager (IM) Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0004 & v8.00.0005

Reason

Second and any subsequent results will have an incorrect test dilution factor in Instrument Manager if the specimen transmission option is set to collated by the Abbott Diagnostics Alinity ci-series instrument and the dilution factor is different between the first and any subsequent results.

Affected products

Instrument Manager (IM) Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0004 & v8.00.0005

Lot or serial number

Core versions 8.00 and higher

Model or catalog number

V8.XX.XX.XX

Companies
Manufacturer
Data Innovations LLC
120 Kimball Avenue Suite 100
South Burlington
05403
Vermont
UNITED STATES